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https://doi.org/10.1177/15266028211064816
Journal of Endovascular Therapy
1 –10
© The Author(s) 2021
Article reuse guidelines:
sagepub.com/journals-permissions
DOI: 10.1177/15266028211064816
www.jevt.org
A SAGE Publication
Category: Clinical Investigation
Introduction
Despite recent technological advances, outcomes after
treatment of patients with peripheral arterial occlusive
disease (PAOD), especially those with chronic limb
threatening ischemia (CLTI), remain poor.1 Treatment of
PAOD primarily involves revascularisation of the limb.
Percutaneous transluminal angioplasty (PTA) as a first
line revascularization strategy over surgical procedures
has been adopted by most vascular centers.2
1064816JETXXX10.1177/15266028211064816Journal of Endovascular TherapyChoke et al
research-article2021
1Sengkang General Hospital, Singapore
2Singapore General Hospital, Singapore
3CVPath Institute Inc., Gaithersburg, MD, USA
4University of Maryland School of Medicine, Baltimore, MD, USA
Corresponding Author:
Edward Choke, Associate Professor and Senior Consultant, Vascular
Surgery, Sengkang General Hospital, 110 Sengkang East Way, Singapore
544886.
Email: Edward.choke.t.c@singhealth.com.sg
MagicTouch PTA Sirolimus Coated Balloon
for Femoropopliteal and Below the Knee
Disease: Results From XTOSI Pilot Study
Up To 12 Months
Edward Choke, MBBS, FRCS, PhD1, Tjun Yip Tang, MD1,2,
Eilane Peh, BSc (Hons)1, Karthikeyan Damodharan, MBBS1,
Shin Chuen Cheng, MBBS1, Jia Sheng Tay, MBBS1, and Aloke V. Finn, MD3,4
Abstract
Introduction: Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral
arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty
(PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK).
Material and Methods: Xtreme Touch-Neo [MagicTouch PTA] Sirolimus Coated Balloon (XTOSI) pilot study is a
prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary
endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio ≤2.4). Secondary
endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause
mortality, and limb salvage success.
Results: Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in
20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications
(Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had
end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length
treated was 227±81 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days,
mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal;
74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6%
(90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and
limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase
between baseline and 6-month toe pressures for both femoropopliteal (57.3±23.3 mm Hg vs 82.5±37.8 mm Hg; p<.001)
and BTK lesions (52.8±19.2 mm Hg vs 70.7±37 mm Hg; p<.037). At 12 months, wound healing rate was 33/39 (84.6%).
Conclusions: MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging
12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials
are needed to investigate the safety and efficacy of SCB for treatment of PAOD.
Keywords
sirolimus, drug coated balloons, peripheral arterial occlusive disease, femoropopliteal, below the knee
2 Journal of Endovascular Therapy 00(0)
Although PTA with conventional balloon angioplasty
(CBA) can achieve more than 90% immediate technical
success, early restenosis resulting in repeat revasculariza-
tion or failed limb salvage is common.3 Efforts to improve
durability of PTA have led to major research endeavors in
the past two decades. Of these, paclitaxel-coated devices
have received the most attention and the highest uptake
among the endovascular community. However, a recent
meta-analyses in December 20184 reported an increased
late all-cause mortality signal for paclitaxel devices in
PAOD. Other subsequent meta-analyses with patient-level
data5 have refuted some of these earlier claims of safety
concerns, and the mortality concerns relating to paclitaxel
remain controversial.
Sirolimus is a potent antiproliferative agent that prevents
activation of smooth muscle cells after vascular injury. Its
anti-restenotic effects have been well-studied in sirolimus-
eluting stent devices in the coronary circulation, where it
has been shown to be safe and more effective than pacli-
taxel devices.6 Data for application of sirolimus in periph-
eral circulation using sirolimus coated balloon (SCB) are
less well studied. It was only recently that small single-arm
first-in-human trials reported the 6-month results using
the SELUTION SLR SCB device for femoropopliteal7 and
below the knee (BTK)8 lesions. We present the 12-month
results of the XTOSI pilot study (Xtreme Touch-Neo
[MagicTouch PTA] Sirolimus Coated Balloon) on the per-
formance of MagicTouch PTA SCB in PAOD patients, for
both femoropopliteal and BTK lesions.
Materials and Methods
Clinical Study Design
The purpose of the XTOSI pilot study was to evaluate the
safety and efficacy of the MagicTouch PTA in patients with
symptoms (claudication, rest pain, or tissue loss) due to
PAOD of the femoropopliteal and BTK arteries. The SCB
device was originally named Xtreme Touch-Neo and it was
renamed Magic Touch PTA during the course of this study
and will be referred to as such for the remainder of this arti-
cle for simplicity.
This study was a first-in-human prospective, single-arm,
open-label, single-center trial. It is a physician-initiated
study and received funding support from Concept Medical
Inc., Florida, USA. Fifty patients were enrolled to receive
the MagicTouch PTA device between November 22, 2018,
and November 21, 2019. The protocol was developed and
conducted in accordance with the International Conference
on Harmonisation/Good Clinical Practice Guideline and
the Declaration of Helsinki (ISO 14155-1 and ISO 14155-
2). It was approved by the local ethics committees (CIRB
2018/2419), and written informed consent was obtained
from all patients.
Investigational Device
The MagicTouch PTA is a novel SCB that utilizes proprie-
tary nanolute technology designed to improve lipophilicity
and bioavailability of sirolimus. Briefly, sirolimus is con-
verted into submicron-sized particles and encapsulated in
phospholipid-drug nanocarriers. The improved lipophilicity
facilitates better adhesion of sirolimus on the balloon sur-
face at dose of 1.27 µg/mm2. Upon inflation of MagicTouch
PTA at the target site, the highly biocompatible submicron
carrier sirolimus is transferred to the vessel wall following
the principle of co-efficient diffusion. Due to its submicron
size, sirolimus can easily penetrate into the adventitial lay-
ers of the artery, and upon variations in body pH, submicron
carrier mimics the body lipids and liberates sirolimus to
achieve anti-restenosis activity in target arteries.
Primary Outcomes
Primary outcome for efficacy was primary patency at 6
months. Primary patency was defined by color duplex ultra-
sonography-derived peak systolic velocity ratio (PSVR) of
≤2.4, in the absence of intervening clinically driven target
lesion revascularization (CD-TLR).
Secondary Outcomes
Secondary outcomes included freedom from CD-TLR and
amputation free survival (AFS).
Other secondary clinical outcomes included changes in
Rutherford classification and toe pressures (TPs), device
success, technical and procedural success, all-cause mortal-
ity, limb salvage success, and wound healing rate.
Inclusion and Exclusion Criteria
Key inclusion criteria were symptomatic patients with
lesions in the infrainguinal arteries that are suitable for
endovascular treatment treated with the MagicTouch PTA
SCB (3–6 mm). For BTK arteries, lesions located in the
proximal 200 mm of the artery are included.
Key exclusion criteria were life expectancy of less than
1 year, failure to achieve less than 30% residual stenosis in
pre-existing lesion after plain balloon angioplasty, and fail-
ure to successfully cross the target lesion with a guide wire.
Treatment
All procedures were performed using percutaneous tech-
niques, with ipsilateral or contralateral access. Following
mandatory pre-dilatation of the target lesion and angio-
graphic confirmation of meeting the inclusion and exclusion
criteria, the MagicTouch PTA was deployed by balloon
inflation to rated burst pressure of 12 atm for 2 min. There
Choke et al 3
was no restriction on the numbers of MagicTouch PTA used
to treat the target lesions. However, when patients had mul-
tilevel disease, treatment with MagicTouch PTA was limited
to either femoropopliteal or BTK according to the discretion
of the physician, to limit the overall dose of the sirolimus.
Adjuvant Medical Therapy
Post procedure, all patients received daily dose aspirin (100
mg) and clopidogrel (75 mg) orally for 6 months at least,
followed by treatment with aspirin alone. Unfractionated
3000 IU heparin was used for procedural anticoagulation.
Statistical Analysis
Descriptive statistics were used to analyze the baseline demo-
graphics, clinical characteristics, and duplex endpoints in
this intention-to-treat population. For time-to-event variables
such as primary patency, freedoms from CD-TLR, and AFS,
survival curves were constructed using Kaplan-Meier esti-
mates. Paired T test analyses were used to analyze TPs, and
p<.05 was considered statistically significant. The IBM®
SPSS® software was used for statistical analyses.
Results
Baseline Patient and Lesion Characteristics
Total of 55 patients were screened, of which 50 were
recruited. Twenty patients received MagicTouch PTA SCB
treatment for femoropopliteal lesions and 30 patients
received it for BTK lesions. Flow diagram is presented in
Figure 1. A total of 40 patients were available for primary
endpoint analyses of the 6-month primary patency (6 had
died, 1 had major limb amputation, 1 withdrew due to frac-
ture leg, and 2 did not attend scheduled follow-up duplex
scan).
Baseline demographics and indications for treatment are
summarized in Table 1. Majority of patients were elderly
males (median age is 67 with interquartile range of 17, 62%
males). This was a high risk group of patients with multiple
medical comorbidities such as diabetes (90%), hyperten-
sion (82%), hyperlipidemia (86%), coronary artery disease
(36%), and renal replacement therapy (20%). Prior to treat-
ment, majority were already on aspirin, and none were on
anticoagulation with warfarin or novel oral anticoagulants
(NOACs). American Society of Anaesthesiologists (ASA)
class were either 3 or 4 in 80% of patients.
Only two patients (4%) were treated for intermittent
claudication and one (2%) for rest pain. The majority of
treatments (47/50, 94%) were performed for limb salvage in
patients with CLTI (gangrene or ulcers; Rutherford scores 5
or 6). The WIFI (Wound, Ischemia, and foot Infection)
scores for those who presented with tissue loss were 4 or
above in the majority (51%), indicating the high severity of
the CLTI. The proportions were similar when analyzed sep-
arately in femoropopliteal and BTK subgroups.
Lesion characteristics and technical details are sum-
marized in Table 2. Overall lesion length was 227±81
mm (193±22 mm in BTK lesions and 277±108 mm in
femoropopliteal lesions). Chronic total occlusion lesions
were 36%, stents were used in 8%, and retrograde access
Figure 1. XTOSI trial flow diagram through 12 months. XTOSI, Xtreme Touch-Neo (MagicTouch PTA) Sirolimus Coated Balloon;
PTA, percutaneous transluminal angioplasty; SCB, sirolimus coated balloon.
4 Journal of Endovascular Therapy 00(0)
was performed in 26% to achieve successful crossing. For
retrograde access, we used sheathless approach, in which
0.018 inch V18 wire (Boston Scientific Corp) was
introduced retrogradely via 21 gauge needle and snared
into an antegradely introduced 4Fr Berenstein catheter for
externalization.
Table 1. Baseline Characteristics and Indications for Treatment.
All
N=50 (% or range)
Femoropopliteal
N=20 (% or range)
Below the knee
N=30 (% or range)
Age 67 (41–89) 67 (49–89) 68 (41–87)
Male 31 (62%) 13 (65%) 18 (60%)
Diabetes 45 (90%) 19 (95%) 26 (87%)
Hypertension 41 (82%) 17 (85%) 24 (80%)
High cholesterol 43 (86%) 17 (85%) 26 (87%)
Dialysis 10 (20%) 4 (20%) 6 (20%)
Coronary artery disease 18 (36%) 12 (60%) 6 (20%)
Previous myocardial infarct 13 (26%) 9 (45%) 4 (13%)
Previous PCI 10 (20%) 5 (25%) 5 (17%)
Previous stroke 6 (12%) 3 (15%) 3 (10%)
Smoker (current or prior) 23 (46%) 11 (55%) 12 (40%)
Pre-treatment medications
Aspirin 34 (68%) 14 (70%) 20 (67%)
Clopidogrel 11 (22%) 4 (20%) 7 (23%)
Beta-blockers 26 (52%) 13 (65%) 13 (43%)
ACE inhibitors 22 (44%) 11 (55%) 11 (37%)
ASA score
2 10 (20%) 3 (15%) 7 (23%)
3 39 (78%) 16 (80%) 23 (77%)
4 1 (2%) 1 (5%) 0
Rutherford scores
3 2 (4%) 2 (10%) 0
4 1 (2%) 0 1 (3%)
5 39 (78%) 14 (70%) 25 (83%)
6 8 (16%) 4 (20%) 4 (13%)
WIFI scores in patients with ulcers/gangrene N=47 (%) N=18 (%) N=29 (%)
1–3 23 (49%) 7 (39%) 16 (55%)
4–8 24 (51%) 11 (61%) 13 (45%)
Abbreviations: PCI, percutaneous coronary intervention; ASA, American Society of Anesthesiologists Score; WIFI, Wound, Ischemia, foot Infection;
ACE, Angiotensin converting enzyme.
Table 2. Lesion Characteristics and Procedural Technical Details.
N=50
Femoropopliteal
N=20
Below the knee
N=30
Lesion characteristics
Total length of lesions (mm) 227±81 277±108 193±22
Stenosis 31 (62%) 10 (50%) 21 (70%)
Occlusion 18 (36%) 9 (45%) 9 (30%)
In stent restenosis 1 (2%) 1 (5%) 0
Procedural details
Stent use after SCB 4 (8%) 4 (20%) 0
Retrograde access to cross target lesion 13 (26%) 9 (45%) 4 (13%)
Fluoroscopic time (min) 28.2±17 33.3±17 24.4±17
Contrast volume (mL) 86.9±49 106.4±33 74.4±54
Abbreviation: SCB, sirolimus coated balloon.
Choke et al 5
Primary Outcome
Primary patency data were available for a total of 40 patients
at 6 months follow-up. The 6-month primary patency was
80% for the overall group; 88.2% for femoropopliteal group
and 74% for BTK group (Table 3 and Figure 2).
Secondary Outcomes at 6 Months
Six-month freedom from CD-TLR was 90.5% for the over-
all group; 94.4% for femoropopliteal group and 87.5% for
BTK group (Table 3 and Figure 3). Six-month AFS was
85.7% for the overall group; 90.0% for femoropopliteal
group and 82.8% for BTK group (Table 3 and Figure 4).
Secondary Outcomes at 12 Months
At 12 months, the primary patency was 66.7% for the over-
all group; 78.6% for femoropopliteal group and 59.1% for
BTK group (Table 3 and Figure 2). Freedom from CD-TLR
was 89.7% for the overall group; 94.1% for femoropopliteal
Table 3. Primary and Secondary Endpoints.
All
N=50
Femoropopliteal
N=20
Below the knee
N=30
Primary endpoint
6-month primary patency 80.0 (32/40) 88.2 (15/17) 74.0 (17/23)
6-month secondary endpoint
Freedom from CD-TLR 90.5 (38/42) 94.4 (17/18) 87.5 (21/24)
Amputation free survival 85.7 (42/49) 90.0 (18/20) 82.8 (24/29)
12-month secondary endpoint
Primary patency 66.7 (24/36) 78.6 (11/14) 59.1 (13/22)
Freedom from CD-TLR 89.7 (35/39) 94.1 (16/17) 86.3 (19/22)
Amputation free survival 81.6 (40/49) 90.0 (18/20) 75.9 (22/29)
All-cause mortality 14.3 (7/49) 10.0 (2/20) 17.2 (5/29)
Limb salvage success 92.9 (39/42) 94.4 (17/18) 91.7 (22/24)
Values are % (n/N).
Abbreviation: CD-TLR, clinically driven target lesion revascularization.
Figure 2. Primary patency.
6 Journal of Endovascular Therapy 00(0)
Figure 3. Freedom from clinically driven target lesion revascularization.
Figure 4. Amputation free survival.
Choke et al 7
and 86.3% for BTK (Table 3 and Figure 3). AFS was 81.6%
for the overall group; 90.0% for femoropopliteal and 75.9%
for BTK (Table 3 and Figure 4). The all-cause mortality was
14.3% (10.0% for femoropopliteal; 17.2% for BTK) and
limb salvage success was 92.9% (94.4% for femoropopli-
teal; 91.7% for BTK; Table 3).
Secondary Clinical Outcomes
Device and technical success were achieved in 100% of
cases (Table 4). There was no instances of distal embo-
lization or acute thrombosis. At 30 days, there was 1
death within 30 days due to ischemic heart disease and 1
major limb amputation (BTK) due to severe sepsis of the
foot.
Paired TP data at both baseline and at 6 months were
available for 34 of 50 patients (16 were excluded at 6
months because 6 had died, 5 did not attend scheduled
TP assessment, 3 underwent trans-metatarsal amputa-
tions, 1 underwent below knee amputation, and 1 with-
drew due to fractured leg; Figure 5). There was a
statistically significant increase in mean TP for both
femoropopliteal (57.3 ± 23.3 mm Hg vs 82.5 ± 37.8 mm
Hg; p<.001) and BTK lesions (52.8 ± 19.2 mm Hg vs
70.7±37 mm Hg; p<.037).
Rutherford scores at 6 and 12 months were available for
42/50 patients (6 months) and 39/50 patients (12 months).
At 12 months, 11 patients were excluded because 7 had
died, 3 underwent below knee amputation, and 1 withdrew
due to fractured leg. At baseline, 88.9% of femoropopliteal
and 95.8% of BTK patients were either Rutherford 5 and 6.
This improved at 6 months in which 88.9% of femoropopli-
teal and 66.7% of BTK patients were Rutherford 0 and at 12
months in which 94.1% of femoropopliteal and 90.9% of
BTK patients were Rutherford 0 (Figure 6). At 6 and 12
months, the wound healing rates were 29/40 (72.5%) and
33/39 (84.6%), respectively.
Discussion
In this first-in-human clinical evaluation of MagicTouch
PTA SCB, XTOSI study showed that there was no peripro-
cedural early safety concerns, with no device complications
or serious adverse events attributable to the device through
to 1 month. It demonstrated promising efficacy and clinical
outcomes at 6 months, similar to other recent publications
evaluating the 6-month performance of other SCBs avail-
able in the market.7,8 In addition, XTOSI is the first study to
report that the efficacy was sustained to 12 months for both
femoropopliteal and BTK lesions.
The 6-month primary patency (88.2%) for femoropopli-
teal lesions for MagicTouch PTA SCB in this study was
similar to that reported by the SELUTION SLR SCB femo-
ropopliteal study7 (88.4%). It was also similar to paclitaxel-
coated balloons (PCB) in previous studies which used the
same binary restenosis duplex endpoint—6-month primary
patency rates of 87% and 90% were reported by RANGER
SFA 9 and LEVANT 210 Lutonix, respectively. There is no
other SCB data to compare the 12-month primary patency
of 78.6% reported in this study. For PCBs, the 12-month
primary patency was 86.4% in RANGER SFA11 and 65.2%
in LEVANT 2.10 It should be stated that any comparison of
outcomes with those from other trials should be approached
with caution and considered as a general guide. The similar
efficacies were achieved despite this study having a pre-
dominant CLTI group compared with the predominant clau-
dicant groups in SELUTION femoropopliteal study,
RANGER SFA11 and LEVANT 210 randomized controlled
trials (RCTs).
For BTK disease, the 6-month primary patency of 74%
for MagicTouch PTA SCB in this study was comparable with
SELUTION SLR SCB for BTK.8 The recently published
PRESTIGE8 study reported 6-month primary patency of
81%, although their definition was per tibial artery rather
than per patient. Our reported 12-month BTK primary
patency of 59% has no other SCB benchmark for comparison
Table 4. Complications Within 30 Days.
Complications within 30 days N=50 (%)
Immediate complications
Device failure 0
Technical failure 0
Distal embolization 0
Target vessel thrombosis 0
Major complications at 30 days
Myocardial infarct 4 (8%)
Congestive cardiac failure 1 (2%)
Stroke 1 (2%)
Pneumonia 2 (4%)
Death at 30 days (ischemic heart disease) 1 (2%)
Amputation at 30 days 1 (2%)
8 Journal of Endovascular Therapy 00(0)
at this time. With regard to PCBs, the SINGA-PACLI RCT12
had similar cohort of CLTI patients to this study and reported
disappointing 6-month angiographic primary patency of only
42% for PCB treatment group and 38% for the CBA group.
Historically, there have been conflicting data regarding the
performance of PCB in BTK. The IN.PACT DEEP13 RCT
evaluated PCB versus CBA in BTK arteries and showed no
benefit in terms of CD-TLR or angiographic late lumen loss,
with a non-significant tendency toward higher major amputa-
tions and lower AFS. The Lutonix BTK RCT14 reported that
6-month primary patency for PCB was 86.7%, but their defi-
nition of primary patency was absence of occlusion rather
Figure 5. Changes in toe pressures between baseline and 6 months. Paired T tests between baseline and 6 months.
*femoropopliteal; **below the knee.
Figure 6. Changes in Rutherford scores for (A) femoropopliteal and (B) BTK lesions at 6 and 12 months. BTK, below the knee.
Choke et al 9
than stenosis (PSVR<2.4) for this study. More recently, there
have been reports of good outcomes with the newer genera-
tion PCB devices—AcoArt II BTK15 reported 6-month angi-
ographic primary patency of 75%—and, therefore, these may
still play a role in BTK in the future.
Data from the JAPAN Critical Limb Ischemia Database
(JCLIMB) of 2906 patients showed that at 30 days after
revascularisation for CLTI patients, the mortality rate
was 2.0% and the major amputation rate was 3.1%.16 Our
reported data were similar, with 30-day mortality of 2% and
30-day major limb amputation also of 2%, raising no early
major safety concerns with the use of SCB within the limits
of this small pilot study and within the limits of low rates of
events. The all-cause mortality at 12 months of 14% in this
study was comparable with the SINGA-PACLI RCT with
similar CLTI patient cohort which reported 12-month all-
cause mortality of 15/70 (21%) and 11/68 (16%) in the PCB
and CBA groups, respectively.12
In terms of biologic therapy for peripheral vasculature,
paclitaxel-based therapies for femoropopliteal indications
is arguably the largest and strongest body of evidence on
device performance ever produced for any peripheral endo-
vascular therapy.10,11,17–19 This contrasts with the coronary
vasculature, in which cardiologists perceive limus to be
superior to paclitaxel because of lower restenosis rates in
the coronary bed following sirolimus-eluting versus pacli-
taxel-eluting stents.20 Sirolimus is a potent antiproliferative
agent that prevents activation of smooth muscle cells after
vascular injury.21 In addition, its immunosuppressive prop-
erties are considered favorable due to the suppression of
local inflammatory responses. It is cytostatic as opposed to
paclitaxel which acts late in the cell reproductive cycle,
interfering with microtubule formation during cell division,
leading to apoptosis and cell death (cytotoxic). Unlike
paclitaxel, sirolimus has a broad therapeutic range21 com-
pared to paclitaxel. The long-term safety of SCB remains to
be established, but the prospects of sirolimus as an effective
anti-restenotic agent for PAOD are promising.
Limitations
First, only a small number of subjects were recruited to this
pilot first-in-human evaluation of MagicTouch PTA SCB.
As such, the study’s results for primary patency must be
interpreted with the small numbers in mind. Second, this
study did not have a case control nor was it randomized.
Third, although this study did not raise early safety con-
cerns, the data were available for 12 months follow-up only.
Together with the small numbers, no conclusions can yet be
made regarding the long-term safety of SCBs. A subsequent
paper is planned when the 24-months follow-up are com-
pleted for all patients. Fourth, another limitation were the
small numbers of patients available for primary patency
assessments at 6 and 12 months, although it must be said
that the deaths and, to a lesser extent, major amputations
were the main reasons for the drop out. This was unavoid-
able as the rates of deaths and amputations were expected
and were in line with other published studies. Only 2 and
3 patients did not attend the scheduled ultrasound follow-
up at 6 and 12 months, respectively, and only 1 withdrew.
Finally, there was no quantitative angiographic follow-up,
and we used duplex follow-up because of concerns regard-
ing contrast nephrotoxicity for this group of frail patients.
Furthermore, the duplex follow-up was not core lab
adjudicated.
Conclusions
XTOSI is a small pilot first-in-human trial of MagicTouch
PTA SCB in symptomatic patients with both femoropopli-
teal and BTK disease which did not raise early safety con-
cerns and reported promising primary patency at 6 months,
with good outcomes sustained to 12 months. RCTs of
MagicTouch PTA SCB versus plain balloon angioplasty are
being planned for both femoropopliteal (FUTURE SFA
RCT) and BTK lesions (FUTURE BTK RCT).
Authors’ Note
The study protocol and 1-year results were presented as an oral
presentation at the LINC meeting, Leipzig, Germany, January 26,
2021, and at the Charing Cross Symposium, April 20, 2021.
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest
with respect to the research, authorship, and/or publication of this
article: E.C. has received honoraria and travel grants from
Biotronik, Medtronic, Bard BD, Abbott, and Concept Medical.
His institution has received research funds from Boston Scientific
and Concept Medical.
Funding
The author(s) disclosed receipt of the following financial support
for the research, authorship, and/or publication of this article: The
XTOSI study received research grant support from Concept
Medical Inc., Tampa, Florida, USA, for the running of the trial.
ORCID iDs
Edward Choke https://orcid.org/0000-0003-0752-503X
Tay Jia Sheng https://orcid.org/0000-0002-0865-467X
Trial Registration
Clinical Use and Safety of the Xtreme Touch-Neo (Magic Touch
PTA) Sirolimus Coated PTA Balloon Catheter in the Treatment of
Infrainguinal Peripheral Arterial Disease (XTOSI): NCT04368091.
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