Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets (SPECIALIST)

The PCI Guideline Research Society

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01670318

SPECIALIST Registry

Details and patient eligibility

About

Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.

Enrollment: 800 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome

2. Male or non-pregnant female

3. Key lesion inclusion criteria as follows

   1. Multi-vessel diseases
   2. Long lesion (lesion length >30mm by visual estimation)
   3. Small vessel disease (reference diameter <2.5mm by visual estimation)
   4. Bifurcation lesion
   5. Ostial lesion
   6. Calcified lesion
   7. Protected or non-protected left main trunk disease
   8. Chronic total occlusion
   9. In stent restenosis of bare metal stent or everolimus-eluting stent

Exclusion criteria

1. Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
2. Serum creatinine level >3.0 mg/dL
3. Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

platinum chromium everolimus-eluting stent

Experimental group

Treatment:

Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)