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

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Genous stent implantation with paclitaxel-eluting balloon dilation Device: Genous stent implantation	Phase II Phase III

MedlinePlus related topics:

Coronary Artery Disease

ChemIDplus related topics:

Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Ulm:

Primary Outcome Measures:

late loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

diameter stenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
binary restenosis rate [ Time Frame: 6 month ] [ Designated as safety issue: No ]
late loss index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
target lesion revascularization [ Time Frame: 2, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
target vessel revascularization [ Time Frame: 2, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
major adverse cardiac events [ Time Frame: 2, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: Yes ]
stent thrombosis [ Time Frame: 2, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Genous stent implantation with paclitaxel-eluting balloon dilation
2: Active Comparator	Device: Genous stent implantation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732953

Contacts


Contact: Jochen Wöhrle, MD	+49 (0)731 500-45001	jochen.woehrle@uniklinik-ulm.de

Locations


Germany
	University of Ulm	Not yet recruiting
	Ulm, Germany, 89081
	Contact: Jochen Wöhrle, MD +49 (0)731 500-45001 jochen.woehrle@uniklinik-ulm.de
	Principal Investigator: Jochen Wöhrle, MD

Sponsors and Collaborators

University of Ulm

B.Braun, Melsungen, Germany

OrbusNeich

Investigators


Principal Investigator:	Jochen Wöhrle, MD	University of Ulm

More Information

Responsible Party:	University of Ulm ( Prof. Dr. Jochen Wöhrle )
Study ID Numbers:	UULM-JW-GP
First Received:	August 7, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00732953
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Ulm:

patients with coronary artery disease

percutaneous coronary intervention

stent implantation

paclitaxel eluting balloon

angiographic follow-up

clinical follow-up

Study placed in the following topic categories:

Arterial Occlusive Diseases

Coronary Disease

Heart Diseases

Paclitaxel

Myocardial Ischemia

Vascular Diseases

Arteriosclerosis

Ischemia

Coronary Artery Disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Cardiovascular Diseases

Antimitotic Agents

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	University of Ulm B.Braun, Melsungen, Germany OrbusNeich
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00732953