Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by University Hospital, Saarland
Sponsor:
Information provided by (Responsible Party):
Bruno Scheller, University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01084408
First received: March 9, 2010
Last updated: November 29, 2011
Last verified: November 2011

March 9, 2010
November 29, 2011
March 2010
March 2013   (final data collection date for primary outcome measure)
Late lumen loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.
Same as current
Complete list of historical versions of study NCT01084408 on ClinicalTrials.gov Archive Site
  • Thrombotic occlusion of the target lesion [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: No ]
  • Revascularization of the target lesion [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: Yes ]
  • Combined clinical endpoint (MACE) [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: Yes ]
    consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death
Same as current
Not Provided
Not Provided
 
Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™
Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary De-novo Stenoses
  • Device: SeQuent®Please (Paclitaxel coated balloon)
    PCI of de-novo lesions
  • Device: Taxus™Liberté™ (Paclitaxel eluting stent)
    PCI of de-novo lesions
  • Active Comparator: Sequent®Please
    Intervention: Device: SeQuent®Please (Paclitaxel coated balloon)
  • Active Comparator: Taxus™Liberté™
    Intervention: Device: Taxus™Liberté™ (Paclitaxel eluting stent)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
March 2018
March 2013   (final data collection date for primary outcome measure)

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 4.3.1.1 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
Both
19 Years and older
No
Contact: Bruno Scheller, Prof. Dr.med +49(0)6841 162 3350 bruno.scheller@uks.eu
Germany
 
NCT01084408
Pac 14
No
Bruno Scheller, University Hospital, Saarland
University Hospital, Saarland
Not Provided
Principal Investigator: Bruno Scheller, Prof. Dr. med Uniklinikum des Saarlandes
University Hospital, Saarland
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP