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

2014-08-27 03:16:02 | BioPortfolio

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.

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

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Restenosis

Intervention

Sequent Please Paclitaxel eluting balloon, Xience V everolimus eluting stent

Location

University Hospitals Leuven
Leuven
Belgium
3000

Status

Recruiting

Source

University Hospital, Gasthuisberg

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:02-0400

Clinical Trials [2132 Associated Clinical Trials listed on BioPortfolio]

Treatment of Drug-eluting Stent (DES) In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

The aim of the study is to assess the efficacy of the Paclitaxel-eluting PTCA - balloon catheter SeQuent® Please to treat in-stent restenoses (ISR) of various drug eluting stents in nativ...

DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent.

The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month...

INDICOR The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent

The INDICOR study is a controlled, prospective, multicenter, randomized, two arm phase-II real world study assessing the acute, 6 months, and 12 months and 3 year outcome of cobalt-chromi...

Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective ...

Treatment of In-Stent Restenosis 2 Study

The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal...

PubMed Articles [666 Associated PubMed Articles listed on BioPortfolio]

Everolimus drug-eluting stent performance in patients with long coronary lesions: The multicenter Longprime registry.

To assess the efficacy and safety of the Xience Prime everolimus-eluting stent (EES) in long coronary lesions in a real-world population.

Angiographic and clinical performance of a paclitaxel coated balloon compared to a 2nd generation sirolimus eluting stent in patients with in-stent restenosis- the BIOLUX randomized controlled trial.

The optimal treatment of in-stent restenosis (ISR) remains unknown. This study evaluates the efficacy and safety of a paclitaxel coated balloon compared to a 2nd generation sirolimus eluting stent in ...

Three-year Follow-up of the Randomized Comparison between Everolimus-eluting Bioresorbable Scaffold and Durable Polymer Everolimus-eluting Metallic Stent in Patients with ST-segment Elevation Myocardial Infarction (TROFI II Trial).

Culotte stenting for coronary bifurcation lesions with 2nd and 3rd generation everolimus-eluting stents: the CELTIC Bifurcation Study.

The aim of this study was to provide contemporary outcome data for patients with de novo coronary disease and Medina 1,1,1 lesions who were treated with a culotte two-stent technique, and to compare t...

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents: BIOFLOW V 2-Year Results.

Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture and bioresorbable polymers. Whether these advancements improve long-term clinical safety and effi...

Medical and Biotech [MESH] Definitions

Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.

An analytical technique for resolution of a chemical mixture into its component compounds. Compounds are separated on an adsorbent paper (stationary phase) by their varied degree of solubility/mobility in the eluting solvent (mobile phase).

Separation systems containing a relatively long-lived parent radionuclide which produces a short-lived daughter in its decay scheme. The daughter can be periodically extracted (milked) by means of an appropriate eluting agent.

The use of balloon CATHETERS to remove emboli by retraction of the balloon that is inflated behind the EMBOLUS.

A balloon-assisted enteroscopy utilizing a flexible endoscope with one overtube balloon control unit.

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