Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to collect real-life data of the Promusâ„¢ stent, the Cypherâ„¢ stent and the Endeavorâ„¢ stent in routine clinical practice, and compare outcomes.
Boston Scientific is developing the present PROENCY registry to collect real world data with the Promusâ„¢ Stent and to compare outcomes to the Cypherâ„¢ and Endeavorâ„¢ 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 Promusâ„¢, the Endeavorâ„¢ and the Cypherâ„¢ stent systems in a real world setting.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promus | Patients intended to be treated with a Promusâ„¢ stent system |
| |
| Endeavor | Patients intended to be treated with an Endeavorâ„¢ stent system (excluded the Endeavorâ„¢ Resoluteâ„¢ stent) |
| |
| Cypher | Patients intended to be treated with a Cypherâ„¢ stent system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Stenting | Device | Drug Eluting stent |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
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:
PROMUS Indications:
CYPHER Indications:
Endeavor Indications:
Exclusion Criteria:
PROMUS Contraindications:
CYPHER Contraindications:
Endeavor Contraindications:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Hamm, MD | Kerckhoff-Klinik GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerckhoff-Klinik GmbH | Bad Nauheim | Hesse | 61231 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided