Back to results

Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Genous stent implantation with paclitaxel-eluting balloon dilation

Genous stent implantation

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring patients with coronary artery disease, percutaneous coronary intervention, stent implantation, paclitaxel eluting balloon, angiographic follow-up, clinical follow-up

Eligibility Criteria

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

Inclusion Criteria:

patients >18 years old
lesion in native coronary artery
de-novo stenosis
indication for revascularization (angina status, myocardial ischemia, positive stress test, pathologic FFR)
range of reference diameter 2.5 to 4.0mm

Exclusion Criteria:

lesion in saphenous vein graft
chronic total occlusion
bifurcation lesion requiring stenting of main and side branch
left main stenosis
restenosis
in-Stent restenosis
contraindication for dual antiplatelet therapy for the following 6 months
coronary aneurysm in target vessel

Sites / Locations

Klinikum Coburg
University of Ulm
Schwarzwald-Baar Klinikum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Genous stent implantation with paclitaxel-eluting balloon therapy

Genous stent implantation

Outcomes

Primary Outcome Measures

Late loss

Secondary Outcome Measures

Diameter stenosis

Binary restenosis rate

Late loss index

Target lesion revascularization

Target vessel revascularization

Major adverse cardiac events

Stent thrombosis

Full Information

NCT ID

NCT00732953

First Posted

August 7, 2008

Last Updated

June 7, 2014

Sponsor

University of Ulm

Collaborators

B. Braun Melsungen AG, OrbusNeich

1. Study Identification

Unique Protocol Identification Number

NCT00732953

Brief Title

Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries

Official Title

Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries - a Randomized Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Ulm

Collaborators

B. Braun Melsungen AG, OrbusNeich

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough endothelialization of stent struts. The Genous stent implantation allows a rapid layer over the stent struts with endothelial progenitor cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis. Local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce restenosis in in-stent restenosis and de-novo lesions in vessels with small reference diameter. The combination of a paclitaxel-eluting balloon and Genous stent implantation may summarized both advantages: a rapid endothelialization limiting the number of stent thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing the risk of restenosis with the subsequent need for revascularization.

6. Conditions and Keywords

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

Coronary Artery Disease

Keywords

patients with coronary artery disease, percutaneous coronary intervention, stent implantation, paclitaxel eluting balloon, angiographic follow-up, clinical follow-up

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Genous stent implantation with paclitaxel-eluting balloon therapy

Arm Title

Arm Type

Active Comparator

Arm Description

Genous stent implantation

Intervention Type

Device

Intervention Name(s)

Genous stent implantation with paclitaxel-eluting balloon dilation

Intervention Description

Genous stent implantation with paclitaxel-eluting balloon therapy

Intervention Type

Device

Intervention Name(s)

Genous stent implantation

Intervention Description

Genous stent implantation

Primary Outcome Measure Information:

Title

Late loss

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Diameter stenosis

Time Frame

6 months

Title

Binary restenosis rate

Time Frame

6 month

Title

Late loss index

Time Frame

6 months

Title

Target lesion revascularization

Time Frame

2, 6, 12, 24, 36, 48, 60 months

Title

Target vessel revascularization

Time Frame

2, 6, 12, 24, 36, 48, 60 months

Title

Major adverse cardiac events

Time Frame

2, 6, 12, 24, 36, 48, 60 months

Title

Stent thrombosis

Time Frame

2, 6, 12, 24, 36, 48, 60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients >18 years old lesion in native coronary artery de-novo stenosis indication for revascularization (angina status, myocardial ischemia, positive stress test, pathologic FFR) range of reference diameter 2.5 to 4.0mm Exclusion Criteria: lesion in saphenous vein graft chronic total occlusion bifurcation lesion requiring stenting of main and side branch left main stenosis restenosis in-Stent restenosis contraindication for dual antiplatelet therapy for the following 6 months coronary aneurysm in target vessel

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jochen Wöhrle, MD

Organizational Affiliation

University of Ulm

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinikum Coburg

City

Coburg

ZIP/Postal Code

96450

Country

Germany

Facility Name

University of Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Schwarzwald-Baar Klinikum

City

Villingen-Schwenningen

ZIP/Postal Code

78011

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

21617163

Citation

Wohrle J, Birkemeyer R, Markovic S, Nguyen TV, Sinha A, Miljak T, Spiess J, Rottbauer W, Rittger H. Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease. Heart. 2011 Aug;97(16):1338-42. doi: 10.1136/hrt.2011.226563. Epub 2011 May 26.

Results Reference

background

PubMed Identifier

26479969

Citation

Seeger J, Markovic S, Birkemeyer R, Rittger H, Jung W, Brachmann J, Rottbauer W, Wohrle J. Paclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease: final 5-year results of a randomized prospective multicenter trial. Coron Artery Dis. 2016 Mar;27(2):84-8. doi: 10.1097/MCA.0000000000000314.

Results Reference

derived

Learn more about this trial

Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries

We'll reach out to this number within 24 hrs