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

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

Study Description
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.

Condition or disease Intervention/treatment
Percutaneous Coronary Intervention Device: Cardiac Stenting

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 Design

Study Type : Observational
Actual Enrollment : 1934 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparative Registry of the PROmus™, ENdeavor™ and CYpher™ Drug Eluting Coronary Stent Systems for the Treatment of Coronary Lesions
Study Start Date : February 2008
Primary Completion Date : March 2010
Study Completion Date : March 2010
Groups and Cohorts

Group/Cohort Intervention/treatment
Promus
Patients intended to be treated with a Promus™ stent system
Device: Cardiac Stenting
Drug Eluting stent
Endeavor
Patients intended to be treated with an Endeavor™ stent system (excluded the Endeavor™ Resolute™ stent)
Device: Cardiac Stenting
Drug Eluting stent
Cypher
Patients intended to be treated with a Cypher™ stent system
Device: Cardiac Stenting
Drug Eluting stent


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00930878


Locations
Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Hessen, Germany, 61231
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Christian Hamm, MD Kerckhoff-Klinik GmbH
More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00930878     History of Changes
Other Study ID Numbers: S2213
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston Scientific Corporation:
registry
drug eluting coronary stent system
observational
prospective
open-label