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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Genous stent implantation with paclitaxel-eluting balloon dilation; Device: Genous stent implantation

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Coburg, Germany, 96450
    • Klinikum Coburg
  • Ulm, Germany, 89081
    • University of Ulm
  • Villingen-Schwenningen, Germany, 78011
    • Schwarzwald-Baar Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Genous stent implantation with paclitaxel-eluting balloon therapy	Device: Genous stent implantation with paclitaxel-eluting balloon dilation; Genous stent implantation with paclitaxel-eluting balloon therapy
ACTIVE_COMPARATOR: 2; Genous stent implantation	Device: Genous stent implantation; Genous stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Late loss	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Diameter stenosis	6 months
Binary restenosis rate	6 month
Late loss index	6 months
Target lesion revascularization	2, 6, 12, 24, 36, 48, 60 months
Target vessel revascularization	2, 6, 12, 24, 36, 48, 60 months
Major adverse cardiac events	2, 6, 12, 24, 36, 48, 60 months
Stent thrombosis	2, 6, 12, 24, 36, 48, 60 months

Collaborators and Investigators

• Sponsor: University of Ulm
• Collaborators: B. Braun Melsungen AG; OrbusNeich
• Investigators: Principal Investigator: Jochen Wöhrle, MD, University of Ulm

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: August 7, 2008
• First Submitted That Met QC Criteria: August 8, 2008
• First Posted (ESTIMATE): August 12, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 10, 2014
• Last Update Submitted That Met QC Criteria: June 7, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; stent implantation; patients with coronary artery disease; paclitaxel eluting balloon; angiographic follow-up; clinical follow-up
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: UULM-JW-GP