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

Coronary Artery Disease Clinical Trial

— ANCHOR  

Official title:

2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01581515
• Other study ID #: 1-2011-0080
• Status: Recruiting
• Phase: Phase 4
• First received: April 11, 2012
• Last updated: April 17, 2012
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: April 2012
• Source: Yonsei University
• Contact: Myeong-Ki Hong, MD.PhD.
• Phone: +82 2 2228 8458
• Email: mkhong61[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Seodaemun-gu/Sinchon-dong

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ratio of the malapposed strut	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	Participants will be followed from first OCT invervention to 3month OCT following intervention	No
Secondary	Incidence of stent malapposition		3months OCT following intervention	No
Secondary	Neointimal coverage(ANCHOR II)		3 month-OCT after stent implantation	No
Secondary	Incidence of plaque prolapse		final postprocedural OCT	No
Secondary	Evaluation of stent expansion		an immediate and post-procedural OCT	No
Secondary	Stent malapposition		on 3 month OCT intervention	No