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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732953
• Other study ID #: UULM-JW-GP
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 7, 2008
• Last updated: June 7, 2014
• Start date: February 2009
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2014
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Genous stent implantation with paclitaxel-eluting balloon dilation
Genous stent implantation with paclitaxel-eluting balloon therapy
• Genous stent implantation
Genous stent implantation

Locations

Country	Name	City	State
Germany	Klinikum Coburg	Coburg
Germany	University of Ulm	Ulm
Germany	Schwarzwald-Baar Klinikum	Villingen-Schwenningen

Sponsors (3)

Lead Sponsor	Collaborator
University of Ulm	B. Braun Melsungen AG, OrbusNeich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Wöhrle 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late loss		6 months	No
Secondary	Diameter stenosis		6 months	No
Secondary	Binary restenosis rate		6 month	No
Secondary	Late loss index		6 months	No
Secondary	Target lesion revascularization		2, 6, 12, 24, 36, 48, 60 months	No
Secondary	Target vessel revascularization		2, 6, 12, 24, 36, 48, 60 months	No
Secondary	Major adverse cardiac events		2, 6, 12, 24, 36, 48, 60 months	Yes
Secondary	Stent thrombosis		2, 6, 12, 24, 36, 48, 60 months	Yes