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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
August 6, 2012
August 13, 2012
September 20, 2017
August 2012
December 2014   (Final data collection date for primary outcome measure)
Safety [ Time Frame: 30 days ]
Composite of new-onset major device-related adverse events.
Same as current
Complete list of historical versions of study NCT01663818 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tack Optimized Balloon Angioplasty (TOBA) Study
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).
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).
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peripheral Vascular Disease
Device: Tack-It Endovascular Stapler
Experimental: Treatment group
Treatment with Tack-IT Endovascular Staple
Intervention: Device: Tack-It Endovascular Stapler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
138
December 2017
December 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01663818
TD 0009
Yes
Not Provided
Not Provided
Intact Vascular
Intact Vascular
Not Provided
Principal Investigator: Marc Bosiers, MD St. Blasius Hospital
Principal Investigator: Dierk Scheinert, MD Park Hospital, Leipzig
Intact Vascular
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP