Tack Optimized Balloon Angioplasty (TOBA) Study

Philips

Status: Completed

Conditions: Peripheral Vascular Disease

Treatments: Device: Tack-It Endovascular Stapler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01663818

TD 0009

Details and patient eligibility

About

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).

Full 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).

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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138 participants in 1 patient group

Treatment group

Experimental group

Description:

Treatment with Tack-IT Endovascular Staple

Treatment:

Device: Tack-It Endovascular Stapler