NCT01065532

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 27, 2023

Status Verified

October 1, 2018

Enrollment Period

3.5 years

First QC Date

February 8, 2010

Last Update Submit

January 26, 2023

Conditions

Restenosis

Keywords

RestenosisPCIDrug-eluting stentDrug-eluting balloonOptical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

  • Stent strut coverage and stent strut apposition(assessed with OCT)

    9 months

Secondary Outcomes (1)

  • 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

    9 months, 12 months, yearly until 5 years

Study Arms (2)

1

ACTIVE COMPARATOR

SeQuent Please Drug-eluting balloon

Device: Sequent Please Paclitaxel eluting balloon

2

ACTIVE COMPARATOR

Xience V Drug-eluting stent

Device: Xience V everolimus eluting stent

Interventions

Sequent Please Paclitaxel eluting balloonDEVICE

Sequent Please Paclitaxel eluting balloon

1
Xience V everolimus eluting stentDEVICE

Xience V everolimus eluting stent

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Adriaenssens T, Dens J, Ughi G, Bennett J, Dubois C, Sinnaeve P, Wiyono S, Coosemans M, Belmans A, D'hooge J, Vrolix M, Desmet W. Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial. EuroIntervention. 2014 Aug;10(4):439-48. doi: 10.4244/EIJV10I4A77.

    PMID: 25138182DERIVED

Study Officials

  • Tom Adriaenssens, MD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

  • Walter Desmet, MD, PhD

    UZ Leuven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

May 1, 2009

Primary Completion

November 1, 2012

Study Completion

December 1, 2016

Last Updated

January 27, 2023

Record last verified: 2018-10

Locations

BE(1)