NCT00776906

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 21, 2015

Status Verified

February 1, 2014

Enrollment Period

5.2 years

First QC Date

October 20, 2008

Last Update Submit

January 19, 2015

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Late Lumen Loss

    6 months

Study Arms (2)

1

EXPERIMENTAL

PTX-coated balloon

Device: Advance® 18PTX® Balloon Catheter

2

ACTIVE COMPARATOR

Bare balloon

Device: Advance® 18LP Balloon Catheter

Interventions

Advance® 18PTX® Balloon CatheterDEVICE
1
Advance® 18LP Balloon CatheterDEVICE
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Heart Center Leipzig/Park Hospital

Leipzig, 04289, Germany

Location

Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Universitat Klinik Tubingen

Tübingen, 72076, Germany

Location

Endosurgery and Lithotripsy Center

Moscow, 111123, Russia

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 22, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 21, 2015

Record last verified: 2014-02

Locations

RU(1)DE(3)