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 (XTOSI)

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

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis; Peripheral Artery Disease
• Intervention / Treatment: Device: Xtreme Touch - Neo sirolimus coated PTA balloon catheter

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 544886
    • Sengkang General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All-comers, real-world registry; Subjects requiring infrainguinal revascularization with the Xtreme Touch - Neo (Magic Touch PTA)

Device: Xtreme Touch - Neo sirolimus coated PTA balloon catheter; The Xtreme Touch (Magic Touch PTA) - Neo Sirolimus PTA Balloon Catheter is the world's first sirolimus coated PTA balloon. The purpose of the X-TOSI all-comers registry is to collect short and long-term clinical performance data on the Xtreme Touch (Magic Touch PTA) -Neo sirolimus PTA balloon catheter in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in real world daily clinical practice.; Other Names: Magic Touch PTA - Sirolimus drug coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Number of Patients with Primary patency	Defined as by duplex ultrasonography-derived peak systolic velocity ratio of < = 2.4	6 months
Safety: Number of Patients with Freedom from Major Adverse Events (MAE) defined as composite of	freedom from device- and procedure-related mortality, and major target limb amputation through to 30 days, and; Freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients with Freedom from clinically-driven TLR	Freedom From Clinically Driven Target Lesion Revascularization	6, 12, and 24 months
Number of Patients with Freedom from clinically-driven TVR	Freedom From Clinically Driven Target Vessel Revascularization	6 and 24 months
Number of Patients with Primary patency	Percentage of subjects with duplex ultrasound Clinical Primary Patency	12 and 24 months
Number of Patients with Freedom from MAE	b. A composite of freedom from device- and procedure-related mortality, and major target limb amputation	12 and 24 months
Number of Patients with Amputation-free survival	Amputation-free survival of patients	6, 12 and 24 months
Number of Patients with Improvement in Rutherford classification	Improvement in Rutherford classification compared to the pre-procedure Rutherford classification	6, 12 and 24 months
Number of Patients with Device success	Successful delivery, inflation, deflation, and retrieval of the Xtreme Touch - Neo balloon catheter.	Day 0
Number of Patients with Technical success	Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation	Day 0
Number of Patients with Procedural success	Participants will be followed for the duration of hospital stay, an expected average of 1-2 days	Participants will be followed for the duration of hospital stay, an expected average of 1-2 days

Collaborators and Investigators

• Sponsor: Concept Medical Inc.
• Investigators: Principal Investigator: Edward Choke Tieng Chek, edward.choke.t.c@singhealth.com.sg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): April 25, 2020
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: PAD; BTK; SFA; DCB; SCB
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: XTOSI Pilot Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No