Clinical trial NCT00930878: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Coronary Intervention
Keywords: registry
drug eluting coronary stent system
observational
prospective
open-label
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 1934
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: at 12-month post index procedure
Secondary outcomes:
measure: 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
timeFrame: at 6 and/or 12 months post index procedure
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
state: Hessen
Study officials:
affiliation: Kerckhoff-Klinik GmbH
name: Christian Hamm, MD
role: PRINCIPAL_INVESTIGATOR
References: