- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01581515
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)
April 17, 2012 updated by: Myeong-Ki Hong, Yonsei University
2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Myeong-Ki Hong, MD.PhD.
- Phone Number: +82 2 2228 8458
- Email: mkhong61@yuhs.ac
Study Locations
-
-
Seodaemun-gu/Sinchon-dong
-
Seoul, Seodaemun-gu/Sinchon-dong, Korea, Republic of, 120-752
- Recruiting
- Severance Hospital
-
Contact:
- Shin-young Park, Staff
- Phone Number: +82 2 2228 0453
- Email: smile@yuhs.ac
-
Principal Investigator:
- Myeong-Ki Hong, MD.PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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
|
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the ratio of the malapposed strut
Time Frame: 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
|
Participants will be followed from first OCT invervention to 3month OCT following intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of stent malapposition
Time Frame: 3months OCT following intervention
|
3months OCT following intervention
|
Neointimal coverage(ANCHOR II)
Time Frame: 3 month-OCT after stent implantation
|
3 month-OCT after stent implantation
|
Incidence of plaque prolapse
Time Frame: final postprocedural OCT
|
final postprocedural OCT
|
Evaluation of stent expansion
Time Frame: an immediate and post-procedural OCT
|
an immediate and post-procedural OCT
|
Stent malapposition
Time Frame: on 3 month OCT intervention
|
on 3 month OCT intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Myeong-Ki Hong, MD.PhD., Severance Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
January 1, 2014
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
April 11, 2012
First Submitted That Met QC Criteria
April 17, 2012
First Posted (Estimate)
April 20, 2012
Study Record Updates
Last Update Posted (Estimate)
April 20, 2012
Last Update Submitted That Met QC Criteria
April 17, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2011-0080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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