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

C

Chinese PLA General Hospital (301 Hospital)

Status

Unknown

Conditions

CHD - Coronary Heart Disease
Percutaneous Coronary Intervention
In-stent Restenosis

Treatments

Procedure: Percutaneous Coronary Intervention under Angiography
Procedure: Percutaneous Coronary Intervention under OCT

Study type

Interventional

Funder types

Other

Identifiers

NCT03809754
Z171100001017158

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 2 patient groups

OCT-guided PCI
Experimental group
Treatment:
Procedure: Percutaneous Coronary Intervention under OCT
Angiography-guided PCI
Sham Comparator group
Treatment:
Procedure: Percutaneous Coronary Intervention under Angiography

Trial contacts and locations

1

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Central trial contact

Lei Gao; Yundai Chen

Data sourced from clinicaltrials.gov

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