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Tack Optimized Balloon Angioplasty (TOBA) Study

This study is currently recruiting participants.
Verified August 2012 by Intact Vascular
Sponsor:
Information provided by (Responsible Party):
Intact Vascular
ClinicalTrials.gov Identifier:
NCT01663818
First received: August 6, 2012
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Peripheral Vascular Disease
 Device: Tack-It Endovascular Stapler
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intact Vascular:

Primary Outcome Measures:
  • Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Composite of new-onset major device-related adverse events.


Estimated Enrollment: 138
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
Treatment with Tack-IT Endovascular Staple
 Device: Tack-It Endovascular Stapler

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663818

Locations
Belgium
Patrick Peeters, MD Recruiting
Bonheiden, Belgium, 2820
Contact: Patrick Peeters, MD     32 15 50 50 11     patrick.peeters@imelda.be    
Sponsors and Collaborators
Intact Vascular
Investigators
Principal Investigator: Marc Bosiers, MD St. Blasius Hospital
Principal Investigator: Dierk Scheinert, MD Park Hospital, Leipzig
  More Information

No publications provided

Responsible Party: Intact Vascular
ClinicalTrials.gov Identifier: NCT01663818     History of Changes
Other Study ID Numbers: TD 0009
Study First Received: August 6, 2012
Last Updated: August 9, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 21, 2013