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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065532
Recruitment Status : Unknown
Verified April 2009 by University Hospital, Gasthuisberg.
Recruitment status was:  Recruiting
First Posted : February 9, 2010
Last Update Posted : February 10, 2010
Information provided by:
University Hospital, Gasthuisberg

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.

Condition or disease Intervention/treatment Phase
Restenosis Device: Sequent Please Paclitaxel eluting balloon Device: Xience V everolimus eluting stent Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Stent strut coverage and stent strut apposition(assessed with OCT) [ Time Frame: 9 months ]

Secondary Outcome Measures :
  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 [ Time Frame: 9 months, 12 months, yearly until 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065532

Contact: Tom Adriaenssens, MD +32 16 34 24 65
Contact: Walter Desmet, MD, PhD +32 16 34 24 65

University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Tom Adriaenssens, MD    +32 16 34 24 65   
Contact: Walter Desmet, MD, PhD    +32 16 34 24 65   
Principal Investigator: Tom Adriaenssens, MD         
Sub-Investigator: Walter Desmet, MD, PhD         
Sub-Investigator: Christophe Dubois, MD         
Sponsors and Collaborators
University Hospital, Gasthuisberg
Principal Investigator: Tom Adriaenssens, MD UZ Leuven
Study Director: Walter Desmet, MD, PhD UZ Leuven

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cardiology deparment University Hospitals Leuven Belgium Identifier: NCT01065532     History of Changes
Other Study ID Numbers: EudraCT 2009-011440-20
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: April 2009

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

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents