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 (ANCHOR)

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Xience Prime everolimus eluting coronary stent; Device: Promus Element everolimus eluting coronary stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01581515

1-2011-0080

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

P-E group

Active Comparator group

Description:

Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime

Treatment:

Device: Promus Element everolimus eluting coronary stent

X-P group

Active Comparator group

Description:

Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime

Treatment:

Device: Xience Prime everolimus eluting coronary stent