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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01581515

Acronym

ANCHOR

Enrollment

100

Registered

2012-04-20

Start date

2012-01-31

Completion date

2014-01-31

Last updated

2012-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEPromus 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

DEVICEXience 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

South Korea

Contacts

Primary ContactMyeong-Ki Hong, MD.PhD.

mkhong61@yuhs.ac+82 2 2228 8458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026