ANCHOR: 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

Sponsor

Yonsei University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01581515

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Promus Element everolimus eluting coronary stent Device: Xience Prime everolimus eluting coronary stent	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: P-E group Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime	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
Active Comparator: X-P group Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime	Device: 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

Arm

Intervention/Treatment

Active Comparator: P-E group

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

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

Active Comparator: X-P group

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

Device: 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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul	Seodaemun-gu/Sinchon-dong	Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Myeong-Ki Hong, MD.PhD., Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Myeong-Ki Hong, MD, Ph D, Yonsei University

ClinicalTrials.gov Identifier:

NCT01581515

Other Study ID Numbers:

1-2011-0080

First Posted:

Apr 20, 2012

Last Update Posted:

Apr 20, 2012

Last Verified:

Apr 1, 2012

Additional relevant MeSH terms:

Coronary Artery Disease

Everolimus

Study Results

No Results Posted as of Apr 20, 2012