Overview

This trial is active, not recruiting.

Condition peripheral vascular disease
Treatment tack-it endovascular stapler
Phase phase 4
Sponsor Intact Vascular
Start date August 2012
End date December 2014
Trial size 138 participants
Trial identifier NCT01663818, TD 0009

Summary

A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment with Tack-IT Endovascular Staple
tack-it endovascular stapler

Primary Outcomes

Measure
Safety
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Rutherford clinical category 2, 3 or 4 - ABI less than or equal to 0.90 - Reference vessel diameter is between 2.5mm and 5.5mm - Target lesion has stenosis greater than or equal to 70% or is occluded - Target lesion is less than or equal to 10cm in length Exclusion Criteria: - Previously implanted stent in the ipsilateral superficial femoral or popliteal artery - Target treatment area is severly calcified (e.g. circumferential calcification or calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm continuously)

Additional Information

Official title Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler
Principal investigator Marc Bosiers, MD
Description Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Intact Vascular.