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

NCT ID: NCT03809754

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-09-01

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OCT-guided PCI

Group Type EXPERIMENTAL

Percutaneous Coronary Intervention under OCT

Intervention Type PROCEDURE

After randomization, subjects receive primary PCI under the guiding of OCT

Angiography-guided PCI

Group Type SHAM_COMPARATOR

Percutaneous Coronary Intervention under Angiography

Intervention Type PROCEDURE

After randomization, subjects receive primary PCI under the guiding of angiography

Interventions

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Percutaneous Coronary Intervention under OCT

After randomization, subjects receive primary PCI under the guiding of OCT

Intervention Type PROCEDURE

Percutaneous Coronary Intervention under Angiography

After randomization, subjects receive primary PCI under the guiding of angiography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yun Dai Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yundai Chen

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Yundai Chen

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Yundai Chen

Role: CONTACT

+8601055499135

Lei Gao

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 39494577 (View on PubMed)

Other Identifiers

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Z171100001017158

Identifier Type: -

Identifier Source: org_study_id

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