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Comparative Registry of the PROmus™, ENdeavor™ and CYpher™ Drug Eluting Stents (ProEnCy)

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.
 
ClinicalTrials.gov Identifier: NCT00930878
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date March 26, 2008
First Posted Date July 2, 2009
Last Update Posted Date February 3, 2017
Study Start Date February 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2009)
Rate of composite patient-oriented hierarchical Major Cardiac Events and its individual components (cardiac death, any Myocardial Infarction (MI) and Target Vessel Revascularisation (TVR) as classified by an External Medical Monitoring Committee. [ Time Frame: at 12-month post index procedure ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 29, 2009)
Technical Success, Stent deliverability, Rate of composite stent-oriented hierarchical Major Cardiac Events and its individual components, TVR rates, TLR rates, Rate of all death, Rate of stent thrombosis [ Time Frame: at 6 and/or 12 months post index procedure ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Registry of the PROmus™, ENdeavor™ and CYpher™ Drug Eluting Stents
Official Title A Comparative Registry of the PROmus™, ENdeavor™ and CYpher™ Drug Eluting Coronary Stent Systems for the Treatment of Coronary Lesions
Brief Summary The purpose of this study is to collect real-life data of the Promus™ stent, the Cypher™ stent and the Endeavor™ stent in routine clinical practice, and compare outcomes.
Detailed Description

Boston Scientific is developing the present PROENCY registry to collect real world data with the Promus™ Stent and to compare outcomes to the Cypher™ and Endeavor™ stents.

All three stents have received CE Mark and are commonly used in Europe. All the data collected in this registry will be from patients treated according to the physician's choices, per Product Directions/Instructions for Use, per approved indications and per local standard of care.

The results from this registry will provide an understanding of the use and outcomes associated with the Promus™, the Endeavor™ and the Cypher™ stent systems in a real world setting.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients eligible and planned for percutaneous coronary intervention (PCI) with any of the three stents and willing to give consent to allow for collection of their clinical data. Patients also need to express willingness to comply with all standard of care follow-up evaluations and medical therapies.
Condition Percutaneous Coronary Intervention
Intervention Device: Cardiac Stenting
Drug Eluting stent
Study Groups/Cohorts
  • Promus
    Patients intended to be treated with a Promus™ stent system
    Intervention: Device: Cardiac Stenting
  • Endeavor
    Patients intended to be treated with an Endeavor™ stent system (excluded the Endeavor™ Resolute™ stent)
    Intervention: Device: Cardiac Stenting
  • Cypher
    Patients intended to be treated with a Cypher™ stent system
    Intervention: Device: Cardiac Stenting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 24, 2011)
1934
Original Actual Enrollment
 (submitted: June 29, 2009)
1959
Actual Study Completion Date March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

All the data collected in this registry will be from patients treated according to the physician's choices, per Product Directions/Instructions for Use, per approved indications and per local standard of care.

Inclusion Criteria:

  • Per PROMUS or CYPHER or Endeavor DFU/IFU

PROMUS Indications:

  • PROMUS™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length 28 mm) with a reference vessel diameter of 2.5 mm - 4.0 mm.

CYPHER Indications:

  • CYPHER SELECT Sirolimus-eluting Coronary Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo and in-stent restenotic lesions (length 30 mm) in native coronary arteries with a reference vessel diameter of 2.25 mm to 5.00 mm.

Endeavor Indications:

  • Endeavor Stent is indicated for improving coronary luminal diameter and reducing restenosis in patients with symptomatic ischemic heart disease in de novo coronary artery lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of < 27 mm.

Exclusion Criteria:

PROMUS Contraindications:

  • Patients in whom anti-platelet and / or anti-coagulant therapy is contraindicated.
  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
  • Patients with a known hypersensitivity or contraindication to everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro - polymers may have an allergic reaction to this implant; therefore, the implant is not recommended for such patients.

CYPHER Contraindications:

  • Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
  • Transplant patients.

Endeavor Contraindications:

  • Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacrolimus, sirolimus or similar drugs or any other analogue or derivative, cobalt, chromium, nickel, molybdenum, or contrast media.
  • Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
  • Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00930878
Other Study ID Numbers S2213
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor Boston Scientific Corporation
Collaborators Not Provided
Investigators
Principal Investigator: Christian Hamm, MD Kerckhoff-Klinik GmbH
PRS Account Boston Scientific Corporation
Verification Date February 2017