Tack Optimized Balloon Angioplasty (TOBA) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intact Vascular
ClinicalTrials.gov Identifier:
NCT01663818
First received: August 6, 2012
Last updated: January 7, 2014
Last verified: January 2014

August 6, 2012
January 7, 2014
August 2012
December 2014   (final data collection date for primary outcome measure)
Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
March 2015
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01663818
TD 0009
Yes
Intact Vascular
Intact Vascular
Not Provided
Principal Investigator: Marc Bosiers, MD St. Blasius Hospital
Principal Investigator: Dierk Scheinert, MD Park Hospital, Leipzig
Intact Vascular
January 2014

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