Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis

Not Applicable

• Conditions: In-stent Restenosis; CHD - Coronary Heart Disease; Percutaneous Coronary Intervention
• Interventions: Procedure: Percutaneous Coronary Intervention under Angiography; Procedure: Percutaneous Coronary Intervention under OCT

• Registration Number: NCT03809754
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23
• Study Start: 2019-03-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angiography-guided PCI	Percutaneous Coronary Intervention under Angiography	-
OCT-guided PCI	Percutaneous Coronary Intervention under OCT	-

Primary Outcome Measures

Name	Time	Method
In-segment late loss at 9 months follow-up	9 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yundai Chen; 🇨🇳 Beijing, China