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
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

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