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

Completed

• Conditions: Percutaneous Coronary Intervention
• Interventions: Device: Cardiac Stenting

• Registration Number: NCT00930878
• Lead Sponsor: Boston Scientific Corporation

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-07-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1934

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Promus	Cardiac Stenting	Patients intended to be treated with a Promus™ stent system
Cypher	Cardiac Stenting	Patients intended to be treated with a Cypher™ stent system
Endeavor	Cardiac Stenting	Patients intended to be treated with an Endeavor™ stent system (excluded the Endeavor™ Resolute™ stent)

Primary Outcome Measures

Name	Time	Method
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.	at 12-month post index procedure

Secondary Outcome Measures

Name	Time	Method
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	at 6 and/or 12 months post index procedure

Trial Locations

Locations (1)

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Hessen, Germany