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

January 21, 2019 updated by: Yun Dai Chen, Chinese PLA General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Yundai Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCT-guided PCI
Procedure: Percutaneous Coronary Intervention under OCT
After randomization, subjects receive primary PCI under the guiding of OCT
Sham Comparator: Angiography-guided PCI
Procedure: Percutaneous Coronary Intervention under Angiography
After randomization, subjects receive primary PCI under the guiding of angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-segment late loss at 9 months follow-up
Time Frame: 9 months
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 17, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z171100001017158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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