Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study — TOBABTK  

Peripheral Artery Disease Clinical Trial

Official title: Prospective, Multicenter Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study for Infrapopliteal Arteries Using the Tack-It Endovascular System™

Status Completed

Clinical Trial Summary

Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from 1.5mm to 4.5mm.

Clinical Trial Description

This first in man (FIM) study is to collect data in support of the safety and performance of the Intact Vascular Tack-It Endovascular System™ for tissue apposition to optimize balloon angioplasty.

Study primary endpoints:

Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 1 month. Endpoint includes any of the following:

• Major amputation - amputation above the ankle

• Re-intervention (surgical or endovascular) in the target limb

• Procedure-related death - any death within 1 month of the index procedure or any MALE

Device Success: The achievement of successful delivery and deployment of the study device(s) at the intended target site(s) and successful withdrawal of the delivery catheter.

Technical Success: Device success (defined above) and the ability of the Tack to resolve post-PTA dissection, demonstrating angiographic patency at the conclusion of the procedure.

Clinical Success: Ability of the Tack to resolve post-PTA dissection and achieve patency at the conclusion of the procedure, without procedure related complications within 48 hours after the index procedure or at hospital discharge, whichever is sooner.

Study secondary endpoints:

The following events will be assessed at 3, 6 and 12 months:

• All-cause mortality

• Amputation of the limb (above the ankle)

• Amputation free survival

• Clinically driven target vessel revascularization (TVR)

• Clinically driven target lesion revascularization (TLR)

• Changes in Rutherford Clinical Category from baseline

The following parameters will be assessed at 1, 3, 6 and 12 months:

• Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared to the baseline TBI obtained prior to discharge

• Doppler Exam (presence of signal)

Study observational endpoint:

The following parameter will be assessed at 6 months (Per local Standard of Care):

• Angiographic percent diameter stenosis ;

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

• NCT number: NCT02235675
• Study type: Interventional
• Source: Philips Clinical & Medical Affairs Global
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Completion date: February 2017