Advance® 18PTX® Balloon Catheter Study

Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery With a Paclitaxel-coated Balloon

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Advance® 18PTX® Balloon Catheter; Device: Advance® 18LP Balloon Catheter

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • Heart Center Leipzig/Park Hospital
  • Rosenheim, Germany, 83022
    • Klinikum Rosenheim
  • Tubingen, Germany, 72076
    • Universitat Klinik Tubingen
• Russian Federation
  • Moscow, Russian Federation, 111123
    • Endosurgery and Lithotripsy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; PTX-coated balloon	Device: Advance® 18PTX® Balloon Catheter
Active Comparator: 2; Bare balloon	Device: Advance® 18LP Balloon Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of Late Lumen Loss	6 months

Collaborators and Investigators

• Sponsor: Cook Group Incorporated

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 20, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (Estimate): October 22, 2008

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 19, 2015
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 08-008; 190007, PCBS