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

Atherosclerosis Clinical Trial

— XTOSI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368091
• Other study ID #: XTOSI Pilot Study
• Status: Completed
• Start date: November 21, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2022
• Source: Concept Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 30, 2021
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Singapore	Sengkang General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Concept Medical Inc.

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Böhm 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Number of Patients with Primary patency	Defined as by duplex ultrasonography-derived peak systolic velocity ratio of < = 2.4	6 months
Primary	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	Number of Patients with Freedom from clinically-driven TLR	Freedom From Clinically Driven Target Lesion Revascularization	6, 12, and 24 months
Secondary	Number of Patients with Freedom from clinically-driven TVR	Freedom From Clinically Driven Target Vessel Revascularization	6 and 24 months
Secondary	Number of Patients with Primary patency	Percentage of subjects with duplex ultrasound Clinical Primary Patency	12 and 24 months
Secondary	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
Secondary	Number of Patients with Amputation-free survival	Amputation-free survival of patients	6, 12 and 24 months
Secondary	Number of Patients with Improvement in Rutherford classification	Improvement in Rutherford classification compared to the pre-procedure Rutherford classification	6, 12 and 24 months
Secondary	Number of Patients with Device success	Successful delivery, inflation, deflation, and retrieval of the Xtreme Touch - Neo balloon catheter.	Day 0
Secondary	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
Secondary	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