Assessment of Stent Malapposition and Neointimal Coverage on Optical coHerence Tomography at Post-procedure and 3 Months After Platinum Chromium Alloy Of the Element™ Stent Implantation

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Device: Promus Element everolimus eluting coronary stent; Device: Xience Prime everolimus eluting coronary stent

• Registration Number: NCT01581515
• Lead Sponsor: Yonsei University

Brief Summary

The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-04
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-17
• Last Update Submitted: 2012-04-17
• Study First Posted: 2012-04-20
• Last Update Posted: 2012-04-20
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient is ≥ 20 years old
• Significant coronary de novo lesion (> 70% by quantitative angiographic analysis) treated by single DES in each vessel.
• Patients with stable angina who are considered for coronary revascularization with stent implantation.
• Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria

• Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
• Reference vessel diameter < 2.5 mm or > 4.0mm and lesion length > 28 mm
• Heavy calcified lesions (definite calcified lesions on angiogram)
• Lesions requiring more than 2 DES in each vessel
• Acute coronary syndrome
• Contraindication to anti-platelet agents
• Treated with any DES within 3 months at other vessel
• Creatinine level ≥ 2.0 mg/dL or ESRD
• Severe hepatic dysfunction (3 times normal reference values)
• Pregnant women or women with potential childbearing
• Life expectancy 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P-E group	Promus Element everolimus eluting coronary stent	Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
X-P group	Xience Prime everolimus eluting coronary stent	Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime

Primary Outcome Measures

Name	Time	Method
the ratio of the malapposed strut	Participants will be followed from first OCT invervention to 3month OCT following intervention	The ratio of the malapposed strut, on an immediate OCT after nominal stent pressure and at a final post-procedure between two different DES; ANCHOR-I

Secondary Outcome Measures

Name	Time	Method
Incidence of stent malapposition	3months OCT following intervention
Neointimal coverage(ANCHOR II)	3 month-OCT after stent implantation
Incidence of plaque prolapse	final postprocedural OCT
Evaluation of stent expansion	an immediate and post-procedural OCT
Stent malapposition	on 3 month OCT intervention

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Seodaemun-gu/Sinchon-dong, Korea, Republic of