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

Not Applicable

• Conditions: Coronary Artery Disease

• Registration Number: NCT01670318
• Lead Sponsor: The PCI Guideline Research Society

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Study First Posted: 2012-08-22
• Last Update Posted: 2012-08-22
• Primary Completion: 2013-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization	12 month

Secondary Outcome Measures

Name	Time	Method
Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site	In hospital
Target lesion revascularization	12 month
Target vessel revascularization	12 month
Myocardial infarction	24 month
Cardiac death	24 month
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization	24 month
Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)	24 month

Trial Locations

Locations (38)

Aichi Medical University Hospital; 🇯🇵 Nagakute, Aichi, Japan

Toyohashi Heart Center; 🇯🇵 Toyohashi, Aichi, Japan

Juntendo University Urayasu Hospital; 🇯🇵 Urayasu, Chiba, Japan

Kokura Memorial Hospital; 🇯🇵 Kitakyushu, Fukuoka, Japan

Hoshi General Hospital; 🇯🇵 Koriyama, Fukushima, Japan

Southern Tohoku Research Institute for Neuroscience; 🇯🇵 Koriyama, Fukushima, Japan

Gunma Prefectural Cardiovascular Center; 🇯🇵 Maebashi, Gunma, Japan

Gunma University Hospital; 🇯🇵 Maebashi, Gunma, Japan

Ota Memorial Hospital; 🇯🇵 Ota, Gunma, Japan

Megumino Hospital; 🇯🇵 Eniwa, Hokkaido, Japan

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