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

NCT00930878 | Completed DMC

• 1 other identifier: S2213
• Study Type: observational
• Target: 1,934
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention

Keywords

registry; drug eluting coronary stent system; observational; prospective; open-label

Outcome Measures

Primary Outcomes (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.

  at 12-month post index procedure

Secondary Outcomes (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

  at 6 and/or 12 months post index procedure

Study Arms (3)

Promus

Patients intended to be treated with a Promus™ stent system

Device: Cardiac Stenting

Endeavor

Patients intended to be treated with an Endeavor™ stent system (excluded the Endeavor™ Resolute™ stent)

Device: Cardiac Stenting

Cypher

Patients intended to be treated with a Cypher™ stent system

Device: Cardiac Stenting

Interventions

Cardiac Stenting DEVICE

Drug Eluting stent

Cypher; Endeavor; Promus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Kerckhoff-Klinik GmbH

Bad Nauheim, Hesse, 61231, Germany

Location

Study Officials

• Christian Hamm, MD

  Kerckhoff-Klinik GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: July 2, 2009
• Study Start: February 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)