Randomized Controlled Study of the Traditional Percutaneous Coronary Intervention and Intervention Using Optical Coherence Tomography of Incomplete Stent Adhesion and Extent of the Formation of Neointima by Resolute Zotarolimus-eluting Stent Insertion
1 other identifier
interventional
115
1 country
1
Brief Summary
Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the parameters of the best stent will be useful. However, for better results for optical coherence tomography in percutaneous interventions have little useful data on the role. Randomized controlled study of the traditional percutaneous coronary intervention and intervention using optical coherence tomography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Dec 2011
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 31, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 5, 2013
May 1, 2013
4.8 years
May 31, 2013
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ratio of the stent strut
Angiographic follow-up with OCT at 6 months
Study Arms (4)
DM, angio group
ACTIVE COMPARATORDM, OCT group
EXPERIMENTALnon DM, angio group
ACTIVE COMPARATORnon DM, OCT group
EXPERIMENTALInterventions
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
Eligibility Criteria
You may qualify if:
- Single lesion in a Single vessel
- Reference vessel diameter 2.5 - 3.5 mm
- Lesion length ≤ 34 mm and ≤ 34 mm stent length
- Stable angina requiring revascularization, patients with unstable angina
- The patient has no difficulty to enforce the follow-up angiography
- Patient is ≥ 20 years old
You may not qualify if:
- Lesions with graft vessel, thrombosis, restenosis, and bifurcation requiring 2 stents
- Reference vessel diameter \< 2.5 mm or \> 4.0mm
- 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)
- Patients with LVEF \< 30%
- Life expectancy 1 year
- Lesions with CTO or left main
- Target vessel of ST-elevation MI
- Lesions requiring overlapped stenting or more than 2 DES in each vessel
- Heavy calcified lesions (definite calcified lesions on angiogram)
- Far distal or tortuous lesions having difficulties in OCT evaluation or follow-up OCT
- Pregnant women or women with potential childbearing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2013
First Posted
June 5, 2013
Study Start
December 1, 2011
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
June 5, 2013
Record last verified: 2013-05