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

January 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. Patient older than 18 years
  2. written informed consent available
  3. patient eligible for percutaneous coronary intervention
  4. patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether BMS or DES)
  5. Target reference vessel diameter measured by QCA: 2-4 mm
  6. Target lesion length measured by QCA < 24 mm
  7. Target lesion stenosis measured by QCA: > 70%- < 100%
  8. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.

Exclusion Criteria:

  1. Left ventricular ejection fraction of < 30%
  2. Impaired renal function (serum creatinine > 2.0 mg/dl)
  3. Target lesion located in bifurcation
  4. Previous and/or planned brachytherapy of target vessel
  5. Lesion of the left main trunk > 50%, unprotected
  6. Known allergies to antiplatelet, anticoagulation therapy, contrast media, paclitaxel or everolimus
  7. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
  8. Patients with a life expectancy of less than one year
  9. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
  10. Patient currently enrolled in other investigational device or drug trial
  11. Patient not able or willing to adhere to follow-up visits
  12. Patients who previously participated in this study. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
SeQuent Please Drug-eluting balloon
Device: Sequent Please Paclitaxel eluting balloon
Sequent Please Paclitaxel eluting balloon
Active Comparator: 2
Xience V Drug-eluting stent
Device: Xience V everolimus eluting stent
Xience V everolimus eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stent strut coverage and stent strut apposition(assessed with OCT)
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Lumen Loss (in-stent) at 9 months In-segment Late Lumen Loss at 9 months Cumulative MACE rate at 9 months Stent thrombosis at all follow-ups Target vessel revascularisation (TVR) at 12 months Device success
Time Frame: 9 months, 12 months, yearly until 5 years
9 months, 12 months, yearly until 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Tom Adriaenssens, MD, UZ Leuven
  • Study Director: Walter Desmet, MD, PhD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2009-011440-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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