Clinical Trials Logo
  1. Home
  2. Restenosis
  3. NCT01065532

SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study — SEDUCE  

Restenosis Clinical Trial

Official title:
Healing Responses After Treatment of Bare Metal Stent Restenosis With Implantation of an Everolimus-eluting Xience V Stent Versus Use of a Paclitaxel-eluting Balloon: Optical Coherence Tomography Study

Clinical Trial Summary

Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study. A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT follow-up at 9 months.

Clinical Trial Description

Background: The optimal treatment of bare metal stent restenosis (implantation of a drug-eluting stent, simple balloon dilatation, CABG) is still not defined. The most used option nowadays is the implantation of a drug-eluting stent (DES). However, this procedure implies application of a double metal layer in the vessel wall, which is linked to delayed healing. Furthermore there might be a higher risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stents. These phenomenon's might give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) were proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising. Aim: To compare healing processes after treatment of BMS ISR with balloon dilatation using DEB versus implantation of DES. Methods: 50 patients with BMS restenosis (SVG and bifurcation lesions will be excluded) will be randomized into two treatment groups: SeQuent Please drug-eluting balloon dilatation (group I) versus implantation of an everolimus-eluting Xience V stent (group II). At 9 months, a control angiography with OCT pullback of the treated segment is planned. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01065532
Study type Interventional
Source Universitaire Ziekenhuizen KU Leuven
Contact
Status Completed
Phase N/A
Start date May 2009
Completion date December 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT01970579 - Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter Phase 3
Completed NCT01722877 - JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions N/A
Completed NCT01861860 - OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA N/A
Recruiting NCT00774917 - Numen Stent Assessment Using OCT Technique in a Single Center Study Phase 2/Phase 3
Completed NCT00493597 - Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of In-stent Restenosis
Completed NCT00647504 - Prospective Clinical Observational Registry Including Consecutive Patients With In-stent Restenosis or Stent Thrombosis N/A
Not yet recruiting NCT01476020 - Is There A LIfe for Drug Eluting Stent (DES) After Discontinuation of Clopidogrel Phase 3
Terminated NCT00780156 - The ITALIC Study: Is There A LIfe for Drug-eluting Stents (DES) After Discontinuation of Clopidogrel N/A
Terminated NCT00712257 - Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis N/A
Recruiting NCT03613337 - Effect of Smoking Status and Genetic Risk Factors on Restenosis and Efficacy of Clopidogrel After de Novo Percutaneous Coronary Intervention
Completed NCT03332264 - Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions N/A
Completed NCT02063672 - Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis N/A
Recruiting NCT05451368 - Neointimal Features in Patients With Restenosis of Calcified Lesions
Completed NCT02649946 - Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft N/A
Completed NCT01632371 - Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 Phase 4
Completed NCT00798954 - Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial Phase 4
Withdrawn NCT03146221 - Search for Restenosis Markers in Lower Limb Arteritis N/A
Completed NCT02790606 - Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA) N/A
Completed NCT01405248 - Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting Phase 3
Completed NCT00987324 - Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis Phase 4