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Clinical Trials/NCT03809754
NCT03809754
Unknown
Not Applicable

Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial

Chinese PLA General Hospital1 site in 1 country240 target enrollmentMarch 1, 2019
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ConditionsCHD - Coronary Heart DiseasePercutaneous Coronary InterventionIn-stent Restenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
CHD - Coronary Heart Disease
Sponsor
Chinese PLA General Hospital
Enrollment
240
Locations
1
Primary Endpoint
In-segment late loss at 9 months follow-up
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
September 1, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yun Dai Chen

Professor

Chinese PLA General Hospital

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

In-segment late loss at 9 months follow-up

Time Frame: 9 months

Secondary Outcomes

  • Rate of 9-month binary restenosis(9 months)
  • Rate of myocardial infarction(12 months)
  • Rates of acute success(1 month)
  • Rate of major adverse cardiovascular events(12 months)
  • Number of participants with all-cause death(12 months)
  • Number of Participants with target lesion failure (TLF)(12 months)

Study Sites (1)

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