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Tack Optimized Balloon Angioplasty (TOBA) Study (TOBA)

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ClinicalTrials.gov Identifier: NCT01663818
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Intact Vascular

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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
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 : August 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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

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Responsible Party: Intact Vascular
ClinicalTrials.gov Identifier: NCT01663818     History of Changes
Other Study ID Numbers: TD 0009
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases