Clinical trial NCT00732953: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Keywords: patients with coronary artery disease
percutaneous coronary intervention
stent implantation
paclitaxel eluting balloon
angiographic follow-up
clinical follow-up
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: B. Braun Melsungen AG
name: OrbusNeich
First posted: 2008-08-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Late loss
timeFrame: 6 months
Secondary outcomes:
measure: Diameter stenosis
timeFrame: 6 months
measure: Binary restenosis rate
timeFrame: 6 month
measure: Late loss index
timeFrame: 6 months
measure: Target lesion revascularization
timeFrame: 2, 6, 12, 24, 36, 48, 60 months
measure: Target vessel revascularization
timeFrame: 2, 6, 12, 24, 36, 48, 60 months
measure: Major adverse cardiac events
timeFrame: 2, 6, 12, 24, 36, 48, 60 months
measure: Stent thrombosis
timeFrame: 2, 6, 12, 24, 36, 48, 60 months
Other outcomes:
Locations:
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Ulm
country: Germany
facility: University of Ulm
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum
Study officials:
affiliation: University of Ulm
name: Jochen Wöhrle, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.