Status unknownNCT03809754Updated Jan 23, 2019

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

An interventional study of Percutaneous Coronary Intervention under OCT and Percutaneous Coronary Intervention under Angiography in CHD - Coronary Heart Disease, Percutaneous Coronary Intervention and In-stent Restenosis, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 240
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

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

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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 240 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

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Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 240 participants (estimated)

Study arms

Experimental
OCT-guided PCI
Procedure: Percutaneous Coronary Intervention under OCT
Sham comparator
Angiography-guided PCI
Procedure: Percutaneous Coronary Intervention under Angiography

Interventions

ProcedurePercutaneous Coronary Intervention under OCT
After randomization, subjects receive primary PCI under the guiding of OCT
ProcedurePercutaneous Coronary Intervention under Angiography
After randomization, subjects receive primary PCI under the guiding of angiography

What researchers measure

Primary outcomes

In-segment late loss at 9 months follow-up
Time frame: 9 months

Secondary outcomes

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

Study locations

1 site

Yundai Chen
Beijing, China

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03809754
Lead sponsor: Chinese PLA General Hospital
Responsible party: Yun Dai Chen (Professor, Chinese PLA General Hospital) — Principal investigator
First posted: Jan 18, 2019
Start date: Mar 1, 2019 (estimated)
Primary completion: Mar 1, 2020 (estimated)
Completion: Sep 1, 2020 (estimated)
Last update: Jan 23, 2019

Study contacts

Yundai Chen

Contact

yundaichen@vip.163.com

+8601055499135

Lei Gao

Contact

nkgaolei2010@126.com

Yundai Chen

principal investigator · Chinese PLA General Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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