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

This study is currently recruiting participants.
Verified April 2009 by University Hospital, Gasthuisberg
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01065532
First received: February 8, 2010
Last updated: February 9, 2010
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention
Restenosis
 Device: Sequent Please Paclitaxel eluting balloon
Device: Xience V everolimus eluting stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Stent strut coverage and stent strut apposition(assessed with OCT) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065532

Contacts
Contact: Tom Adriaenssens, MD +32 16 34 24 65 tom.adriaenssens@uzleuven.be
Contact: Walter Desmet, MD, PhD +32 16 34 24 65 walter.desmet@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Tom Adriaenssens, MD     +32 16 34 24 65     tom.adriaenssens@uzleuven.be    
Contact: Walter Desmet, MD, PhD     +32 16 34 24 65     walter.desmet@uzleuven.be    
Principal Investigator: Tom Adriaenssens, MD            
Sub-Investigator: Walter Desmet, MD, PhD            
Sub-Investigator: Christophe Dubois, MD            
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Tom Adriaenssens, MD UZ Leuven
Study Director: Walter Desmet, MD, PhD UZ Leuven
  More Information

No publications provided

Responsible Party: Cardiology deparment University Hospitals Leuven Belgium
ClinicalTrials.gov Identifier: NCT01065532     History of Changes
Other Study ID Numbers: EudraCT 2009-011440-20
Study First Received: February 8, 2010
Last Updated: February 9, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
Restenosis
PCI
Drug-eluting stent
Drug-eluting balloon
Optical Coherence Tomography

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Everolimus
Sirolimus
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013