Tack Optimized Balloon Angioplasty (TOBA) Study (TOBA)

April 2, 2021 updated by: Philips Clinical & Medical Affairs Global

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium, 2820
        • Patrick Peeters, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 30 days
Composite of new-onset major device-related adverse events.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD 0009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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