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Advance® 18PTX® Balloon Catheter Study

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Advance® 18PTX® Balloon Catheter
Advance® 18LP Balloon Catheter
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

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

Key Inclusion Criteria:

  • Age >18 years.
  • Able to provide informed consent.
  • Has at least one de novo or restenotic lesion(s) with > 70% stenosis documented angiographically of the SFA or popliteal artery. If more than one lesion requires intervention, only one should be treated as a study lesion.

Key Exclusion Criteria:

  • Has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure.
  • Lack of at least one patent runoff vessel with < 50% stenosis throughout its course.
  • Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.

Sites / Locations

  • Heart Center Leipzig/Park Hospital
  • Klinikum Rosenheim
  • Universitat Klinik Tubingen
  • Endosurgery and Lithotripsy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

PTX-coated balloon

Bare balloon

Outcomes

Primary Outcome Measures

Evaluation of Late Lumen Loss

Secondary Outcome Measures

Full Information

First Posted
October 20, 2008
Last Updated
January 19, 2015
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00776906
Brief Title
Advance® 18PTX® Balloon Catheter Study
Official Title
Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery With a Paclitaxel-coated Balloon
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

Brief Summary
The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the superficial femoral artery and popliteal artery.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PTX-coated balloon
Arm Title
2
Arm Type
Active Comparator
Arm Description
Bare balloon
Intervention Type
Device
Intervention Name(s)
Advance® 18PTX® Balloon Catheter
Intervention Type
Device
Intervention Name(s)
Advance® 18LP Balloon Catheter
Primary Outcome Measure Information:
Title
Evaluation of Late Lumen Loss
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Age >18 years. Able to provide informed consent. Has at least one de novo or restenotic lesion(s) with > 70% stenosis documented angiographically of the SFA or popliteal artery. If more than one lesion requires intervention, only one should be treated as a study lesion. Key Exclusion Criteria: Has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure. Lack of at least one patent runoff vessel with < 50% stenosis throughout its course. Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.
Facility Information:
Facility Name
Heart Center Leipzig/Park Hospital
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Klinikum Rosenheim
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Universitat Klinik Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Endosurgery and Lithotripsy Center
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation

12. IPD Sharing Statement

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Advance® 18PTX® Balloon Catheter Study

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