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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention under OCT
Percutaneous Coronary Intervention under Angiography
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CHD - Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yundai Chen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

OCT-guided PCI

Angiography-guided PCI

Arm Description

Outcomes

Primary Outcome Measures

In-segment late loss at 9 months follow-up

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2019
Last Updated
January 21, 2019
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03809754
Brief Title
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
Official Title
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHD - Coronary Heart Disease, Percutaneous Coronary Intervention, In-stent Restenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCT-guided PCI
Arm Type
Experimental
Arm Title
Angiography-guided PCI
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention under OCT
Intervention Description
After randomization, subjects receive primary PCI under the guiding of OCT
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention under Angiography
Intervention Description
After randomization, subjects receive primary PCI under the guiding of angiography
Primary Outcome Measure Information:
Title
In-segment late loss at 9 months follow-up
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Rates of acute success
Time Frame
1 month
Title
Rate of 9-month binary restenosis
Time Frame
9 months
Title
Number of Participants with target lesion failure (TLF)
Time Frame
12 months
Title
Rate of major adverse cardiovascular events
Time Frame
12 months
Title
Number of participants with all-cause death
Time Frame
12 months
Title
Rate of myocardial infarction
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yundai Chen
Phone
+8601055499135
Email
yundaichen@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Gao
Email
nkgaolei2010@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yundai Chen
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yundai Chen
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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