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

A Comparative Registry of the PROmus™, ENdeavor™ and CYpher™ Drug Eluting Coronary Stent Systems for the Treatment of Coronary Lesions

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1934

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Bad Nauheim, Hessen, Germany, 61231
      • Kerckhoff-Klinik GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Christian Hamm, MD, Kerckhoff-Klinik GmbH

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: March 26, 2008
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (Estimate): July 2, 2009

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: open-label; prospective; registry; observational; drug eluting coronary stent system
• Other Study ID Numbers: S2213 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO