Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
1 other identifier
interventional
240
1 country
1
Brief Summary
This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
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
First Submitted
Initial submission to the registry
January 15, 2019
CompletedFirst Posted
Study publicly available on registry
January 18, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJanuary 23, 2019
January 1, 2019
1 year
January 15, 2019
January 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
In-segment late loss at 9 months follow-up
9 months
Secondary Outcomes (6)
Rates of acute success
1 month
Rate of 9-month binary restenosis
9 months
Number of Participants with target lesion failure (TLF)
12 months
Rate of major adverse cardiovascular events
12 months
Number of participants with all-cause death
12 months
- +1 more secondary outcomes
Study Arms (2)
OCT-guided PCI
EXPERIMENTALAngiography-guided PCI
SHAM COMPARATORInterventions
After randomization, subjects receive primary PCI under the guiding of OCT
After randomization, subjects receive primary PCI under the guiding of angiography
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Patients with angina or evidence of myocardial ischaemia
- Patients with restenotic lesions in a previously DES area of a coronary artery
- Patients suitable to receive any types of percutaneous coronary intervention (including balloon angioplasty and stent implantation)
- The stent diameter of DES-ISR is 2.5mm to 4.0mm
- Target lesion length \< 30mm
- Target lesion stenosis ≥ 70% diameter stenosis on visual assessment, or ≥ 50% diameter stenosis and with evidence of myocardial ischaemia ischemic
You may not qualify if:
- Patients with acute myocardial infarction with 1 week
- Patients with evidence of extensive thrombosis in the target vessel
- Patients with left main coronary artery disease
- Patients with cardiogenic shock, left ventricular ejection fraction \< 40%,significant renal dysfunction and severe heart valve disease
- Patients who had cerebral stroke within 6 months before PCI
- Patients with a life expectancy \< 1 year
- Patients not able to adhere to follow-up visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yundai Chen
Beijing, China
Related Publications (1)
Han Y, Yuan X, Wang W, Wang N, Zhang Y, Jing J, Chen Y, Gao L. Clinical Significance of Optical Coherence Tomography-Guided Percutaneous Coronary Intervention for In-Stent Restenosis Within Drug-Eluting Stents: Impact on Patient Outcomes. J Am Heart Assoc. 2024 Nov 5;13(21):e033954. doi: 10.1161/JAHA.123.033954. Epub 2024 Nov 4.
PMID: 39494577DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yundai Chen
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 15, 2019
First Posted
January 18, 2019
Study Start
March 1, 2019
Primary Completion
March 1, 2020
Study Completion
September 1, 2020
Last Updated
January 23, 2019
Record last verified: 2019-01