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

NCT04368091 | Completed DMC

• 1 other identifier: XTOSI Pilot Study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease; Atherosclerosis

Keywords

PAD; BTK; SFA; DCB; SCB

Outcome Measures

Primary Outcomes (2)

• 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

  1. freedom from device- and procedure-related mortality, and major target limb amputation through to 30 days, and 2. Freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure.

  6 months

Secondary Outcomes (9)

• Number of Patients with Freedom from clinically-driven TLR

  6, 12, and 24 months

• Number of Patients with Freedom from clinically-driven TVR

  6 and 24 months

• Number of Patients with Primary patency

  12 and 24 months

• Number of Patients with Freedom from MAE

  12 and 24 months

• Number of Patients with Amputation-free survival

  6, 12 and 24 months

Study Arms (1)

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

Interventions

Xtreme Touch - Neo sirolimus coated PTA balloon catheter DEVICE

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.

Also known as: Magic Touch PTA - Sirolimus drug coated balloon

All-comers, real-world registry

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Concept Medical Inc.: lead

Study Sites (1)

Sengkang General Hospital

Singapore, 544886, Singapore

Location

Related Publications (3)

• 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.

  PMID: 27539695 BACKGROUND

• 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.

  PMID: 27069105 BACKGROUND

• 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.

  PMID: 28964764 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Edward Choke Tieng Chek

  edward.choke.t.c@singhealth.com.sg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: November 21, 2018
• Primary Completion: April 25, 2020
• Study Completion: December 30, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)