Clinical trial NCT04368091: Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA)- Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease
Official title: XTOSI Pilot Study: Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA) - Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Atherosclerosis
Keywords: PAD
BTK
SFA
DCB
SCB
Lead sponsor: Concept Medical Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from an all-comers patient population with all subjects requiring infrainguinal revascularization with the Xtreme Touch - Neo.

Brief summary: This study postulates that the application of Sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via Sirolimus coated balloon (SCB) will be safe and will result in better arterial patency in infrainguinal peripheral arterial disease (PAD). The aim is to evaluate the efficacy (12 month freedom from clinically driven target lesion revascularisation) and safety (freedom from major adverse events) of sirolimus coated balloons in the treatment of infrainguinal PAD.

Detailed description: It is imperative to have effective treatment strategies for PAD which can maintain the patency of arteries. The current standard of care for PAD is angioplasty which includes usage of drug coated balloons (DCB). Paclitaxel is the only anti-proliferative drug available in all currently available DCB technology. Sirolimus is another highly effective anti-proliferative drug of immense potential as demonstrated by superior results in Sirolimus drug eluting stents in coronary disease. The physical properties of Sirolimus have made it challenging for it to be similarly applied to DCB technology and it is only due to recent advances in nanotechnology that it is now possible to develop Sirolimus coated balloons (SCB), which is the study device used in this study. The study device allows delivery and deposition of sirolimus to the arterial wall. By applying this agent into lesions in peripheral arterial disease, this study aim to effectively reduce neointimal hyperplasia, and therefore prolong the patency of the artery and improve our limb salvage rates for PAD and CLI patients. Subjects will be followed up in the clinic at 6 month, 12 month, and 24 month post-intervention to assess primary and secondary outcome of safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 21 years or minimum age
* Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable
* Lesion(s) in the infrainguinal arteries between 3 to 6mm which are suitable for endovascular treatment treated with the Xtreme Touch - Neo sirolimus PTA balloon catheter. For below the knee (BTK) arteries, lesions located in the proximal 200mm of the artery.

Exclusion Criteria:

* Life expectancy ≤ 1 year
* Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet
* Subject is pregnant or planning to become pregnant during the course of the study
* Failure to achieve less than 30% residual stenosis in pre-existing lesion after plain balloon angioplasty
* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations

Primary outcomes:
measure: Efficacy: Number of Patients with Primary patency
timeFrame: 6 months
measure: Safety: Number of Patients with Freedom from Major Adverse Events (MAE) defined as composite of
timeFrame: 6 months
Secondary outcomes:
measure: Number of Patients with Freedom from clinically-driven TLR
timeFrame: 6, 12, and 24 months
measure: Number of Patients with Freedom from clinically-driven TVR
timeFrame: 6 and 24 months
measure: Number of Patients with Primary patency
timeFrame: 12 and 24 months
measure: Number of Patients with Freedom from MAE
timeFrame: 12 and 24 months
measure: Number of Patients with Amputation-free survival
timeFrame: 6, 12 and 24 months
measure: Number of Patients with Improvement in Rutherford classification
timeFrame: 6, 12 and 24 months
measure: Number of Patients with Device success
timeFrame: Day 0
measure: Number of Patients with Technical success
timeFrame: Day 0
measure: Number of Patients with Procedural success
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Sengkang General Hospital
Study officials:
affiliation: edward.choke.t.c@singhealth.com.sg
name: Edward Choke Tieng Chek
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giacoppo D, Cassese S, Harada Y, Colleran R, Michel J, Fusaro M, Kastrati A, Byrne RA. Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials. JACC Cardiovasc Interv. 2016 Aug 22;9(16):1731-42. doi: 10.1016/j.jcin.2016.06.008.
citation: Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.
citation: Verheye S, Vrolix M, Kumsars I, Erglis A, Sondore D, Agostoni P, Cornelis K, Janssens L, Maeng M, Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2029-2037. doi: 10.1016/j.jcin.2017.06.021. Epub 2017 Sep 27.