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Tack Optimized Balloon Angioplasty (TOBA) Study (TOBA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663818
First Posted: August 13, 2012
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Intact Vascular
  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
Peripheral Vascular Disease Device: Tack-It Endovascular Stapler

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Intact Vascular:

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


Estimated Enrollment: 138
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663818


Locations
Belgium
Patrick Peeters, MD
Bonheiden, Belgium, 2820
Sponsors and Collaborators
Intact Vascular
Investigators
Principal Investigator: Marc Bosiers, MD St. Blasius Hospital
Principal Investigator: Dierk Scheinert, MD Park Hospital, Leipzig
  More Information

Responsible Party: Intact Vascular
ClinicalTrials.gov Identifier: NCT01663818     History of Changes
Other Study ID Numbers: TD 0009
First Submitted: August 6, 2012
First Posted: August 13, 2012
Last Update Posted: September 20, 2017
Last Verified: September 2017

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