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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)

This study is currently recruiting participants.
Verified April 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Myeong-Ki Hong, Yonsei University
ClinicalTrials.gov Identifier:
NCT01581515
First received: April 11, 2012
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • the ratio of the malapposed strut [ Time Frame: Participants will be followed from first OCT invervention to 3month OCT following intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3months OCT following intervention ] [ Designated as safety issue: No ]
  • Neointimal coverage(ANCHOR II) [ Time Frame: 3 month-OCT after stent implantation ] [ Designated as safety issue: No ]
  • Incidence of plaque prolapse [ Time Frame: final postprocedural OCT ] [ Designated as safety issue: No ]
  • Evaluation of stent expansion [ Time Frame: an immediate and post-procedural OCT ] [ Designated as safety issue: No ]
  • Stent malapposition [ Time Frame: on 3 month OCT intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581515

Contacts
Contact: Myeong-Ki Hong, MD.PhD. +82 2 2228 8458 mkhong61@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Seodaemun-gu/Sinchon-dong, Korea, Republic of, 120-752
Contact: Shin-young Park, Staff     +82 2 2228 0453     smile@yuhs.ac    
Principal Investigator: Myeong-Ki Hong, MD.PhD            
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Myeong-Ki Hong, MD.PhD. Severance Hospital
  More Information

No publications provided

Responsible Party: Myeong-Ki Hong, MD, Ph D, Yonsei University
ClinicalTrials.gov Identifier: NCT01581515     History of Changes
Other Study ID Numbers: 1-2011-0080
Study First Received: April 11, 2012
Last Updated: April 17, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013