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Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™ (PEPCAD-DEBonly)

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: NCT01084408
Recruitment Status : Active, not recruiting
First Posted : March 10, 2010
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
Bruno Scheller, University Hospital, Saarland

Brief Summary:
The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.

Condition or disease Intervention/treatment Phase
Coronary De-novo Stenoses Device: SeQuent®Please (Paclitaxel coated balloon) Device: Taxus™Liberté™ (Paclitaxel eluting stent) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon
Study Start Date : March 2010
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: Sequent®Please Device: SeQuent®Please (Paclitaxel coated balloon)
PCI of de-novo lesions

Active Comparator: Taxus™Liberté™ Device: Taxus™Liberté™ (Paclitaxel eluting stent)
PCI of de-novo lesions

Primary Outcome Measures :
  1. Late lumen loss [ Time Frame: 6 months ]
    Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.

Secondary Outcome Measures :
  1. Thrombotic occlusion of the target lesion [ Time Frame: 30 days, 6, 12, 24, 60 months ]
  2. Revascularization of the target lesion [ Time Frame: 30 days, 6, 12, 24, 60 months ]
  3. Myocardial infarction [ Time Frame: 30 days, 6, 12, 24, 60 months ]
  4. Death [ Time Frame: 30 days, 6, 12, 24, 60 months ]
  5. Combined clinical endpoint (MACE) [ Time Frame: 30 days, 6, 12, 24, 60 months ]
    consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Clinical evidence of stable or unstable angina or a positive functional study
  • Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see Definition of lesion types)
  • Diameter stenosis > 70% (visual estimate)
  • Vessel diameter 2.5 - 3.5 mm
  • Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
  • Signed patient informed consent form
  • Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol

Exclusion Criteria:

  • Left ventricular ejection fraction of < 30%
  • Visible thrombus proximal to the lesion
  • Expection that treatment with devices other than PTCA will be required for this lesion.
  • Stenosis is within a bypass graft
  • Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated
  • Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
  • Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) >3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)
  • Chronic renal insufficiency with serum creatinine > 2.0 mg%
  • Significant gastrointestinal (GI) bleed within the past six months.
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment.
  • Participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of 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): NCT01084408

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Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann
Postdam, Brandenburg, Germany, 14467
Medizinisches Versorgungszentrum
Hamburg, Germany, 22527
Sponsors and Collaborators
University Hospital, Saarland
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Principal Investigator: Bruno Scheller, Prof. Dr. med Uniklinikum des Saarlandes

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Responsible Party: Bruno Scheller, MD, University Hospital, Saarland Identifier: NCT01084408    
Other Study ID Numbers: Pac 14
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Bruno Scheller, University Hospital, Saarland:
coronary stenoses
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action