Tack Optimized Balloon Angioplasty (TOBA) Study

• Sponsor: Philips Clinical & Medical Affairs Global (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01663818
• Collaborator: (none)
• Enrollment: 138
• Location: 1
• Arm: 1
• Duration (Months): 38
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Disease	Device: Tack-It Endovascular Stapler	N/A

Detailed 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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 138 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group Treatment with Tack-IT Endovascular Staple	Device: Tack-It Endovascular Stapler

Outcome Measures

Primary Outcome Measures

1. Safety [30 days]

   Composite of new-onset major device-related adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Patrick Peeters, MD	Bonheiden		Belgium	2820

Sponsors and Collaborators

• Philips Clinical & Medical Affairs Global

Investigators

• Principal Investigator: Marc Bosiers, MD, St. Blasius Hospital
• Principal Investigator: Dierk Scheinert, MD, Park Hospital, Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Clinical & Medical Affairs Global
• ClinicalTrials.gov Identifier: NCT01663818
• Other Study ID Numbers: TD 0009
• First Posted: Aug 13, 2012
• Last Update Posted: Apr 5, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease

Study Results

No Results Posted as of Apr 5, 2021