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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 90
Study Start Date: March 2010
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084408

Contacts
Contact: Bruno Scheller, Prof. Dr.med +49(0)6841 162 3350 bruno.scheller@uks.eu

Locations
Germany
Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann Recruiting
Postdam, Brandenburg, Germany, 14467
Contact: Franz Xaver Kleber, Prof. Dr. med       fxkleber@klinikumevb.de   
Principal Investigator: Franz Xaver Kleber, Prof. Dr. med         
Medizinisches Versorgungszentrum Recruiting
Hamburg, Germany, 22527
Contact: Detlef Mathey, Prof. Dr. med    +49(0)408890090    mathey@herz-hh.de   
Principal Investigator: Detlef Mathey, Prof. Dr. med         
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Bruno Scheller, Prof. Dr. med Uniklinikum des Saarlandes
  More Information

No publications provided

Responsible Party: Bruno Scheller, MD, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01084408     History of Changes
Other Study ID Numbers: Pac 14
Study First Received: March 9, 2010
Last Updated: November 29, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:
de-novo
coronary stenoses
PEPCAD
DEBonly
Paclitaxel

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014