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NCT01663818 Clinical Trial

Tack Optimized Balloon Angioplasty (TOBA) Study

Peripheral Vascular Disease Clinical Trial

— TOBA  

Official title:
Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01663818
Other study ID # TD 0009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2012
Est. completion date October 2015

Study information
Verified date April 2021
Source Philips Clinical & Medical Affairs Global
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Completed
Enrollment 138
Est. completion date October 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Tack-It Endovascular Stapler

Locations
Country Name City State
Belgium Patrick Peeters, MD Bonheiden

Sponsors (1)
Lead Sponsor Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Composite of new-onset major device-related adverse events. 30 days
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