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Tack Optimized Balloon Angioplasty (TOBA) Study (TOBA)

Primary Purpose

Peripheral Vascular Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Tack-It Endovascular Stapler
Sponsored by
Philips Clinical & Medical Affairs Global
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Patrick Peeters, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Treatment with Tack-IT Endovascular Staple

Outcomes

Primary Outcome Measures

Safety
Composite of new-onset major device-related adverse events.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2012
Last Updated
April 2, 2021
Sponsor
Philips Clinical & Medical Affairs Global
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1. Study Identification

Unique Protocol Identification Number
NCT01663818
Brief Title
Tack Optimized Balloon Angioplasty (TOBA) Study
Acronym
TOBA
Official Title
Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Treatment with Tack-IT Endovascular Staple
Intervention Type
Device
Intervention Name(s)
Tack-It Endovascular Stapler
Primary Outcome Measure Information:
Title
Safety
Description
Composite of new-onset major device-related adverse events.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bosiers, MD
Organizational Affiliation
St. Blasius Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dierk Scheinert, MD
Organizational Affiliation
Park Hospital, Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patrick Peeters, MD
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium

12. IPD Sharing Statement

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Tack Optimized Balloon Angioplasty (TOBA) Study

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