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COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

Primary Purpose

Multivessel Coronary Artery Disease, Ischemia, Vulnerable Plaque

Status
Recruiting
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
PCI revascularization strategy based on combined FFR and OCT assessment
PCI revascularization strategy based FFR assessment
Sponsored by
Diagram B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multivessel Coronary Artery Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients undergoing PCI, aged 30-80 years with any clinical presentation
  2. Angiographic criteria: presence of ≥ 2 de novo target lesions* located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision)

Angiographic criteria target lesion* (all criteria I-IV should be applicable):

I. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation)

*Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have ≥ 2 target lesions or one culprit and ≥ 1 target lesion.

Exclusion Criteria:

  1. Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision)
  2. Lesion located in a grafted segment or in a vein graft
  3. In-stent restenosis lesions
  4. Left main trifurcation
  5. Left main lesion stand-alone (without other lesions)
  6. Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous)
  7. Chronic total occlusion
  8. Spontaneous coronary dissection
  9. Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years
  10. Patients with left ventricle (LV) function less than 30%
  11. Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
  12. Life expectancy less than 3 years

Sites / Locations

  • Different countries in Europe, Asia Pacific and CanadaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment

MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)

Arm Description

MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment

MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)

Outcomes

Primary Outcome Measures

cardiac death, any myocardial infarction (MI) or any clinically-driven revascularization at 24 months
cardiac death, any myocardial infarction (MI) or any clinically-driven revascularization at 24 months

Secondary Outcome Measures

Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events in all lesions with a FFR between 0.76-0.80 left untreated in the experimental arm
Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events in all lesions with a FFR between 0.76-0.80 left untreated in the experimental arm
Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months
Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months

Full Information

First Posted
April 11, 2022
Last Updated
April 11, 2022
Sponsor
Diagram B.V.
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT05333068
Brief Title
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
Official Title
COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
March 16, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diagram B.V.
Collaborators
Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation.
Detailed Description
The published COMBINE trial shows that patients carrying an OCT-detected thin-cap atheroma have a fivefold higher rate of the primary endpoint compared to patients without vulnerable lesion morphology, despite absence of ischemia. The most important finding of this trial is that not ischemia, but underlying lesion morphology could be the most important factor that predicts future adverse events. Together with the recently published ISCHEMIA trial, where ischemia guided revascularization failed to improve clinical outcomes compared to medical treatment, the COMBINE trial leads to a new way of thinking in interventional cardiology and also opens the door for new treatment strategies where a combined ischemic and morphologic assessment could lead to better clinical outcomes. The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation. The COMBINE-INTERVENE Trial is the first in line trial that will test focal percutaneous stenting for vulnerable plaque lesions independently from ischemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multivessel Coronary Artery Disease, Ischemia, Vulnerable Plaque, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single blind
Allocation
Randomized
Enrollment
1222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment
Arm Type
Experimental
Arm Description
MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment
Arm Title
MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)
Arm Type
Sham Comparator
Arm Description
MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)
Intervention Type
Procedure
Intervention Name(s)
PCI revascularization strategy based on combined FFR and OCT assessment
Intervention Description
PCI revascularization strategy based on combined FFR and OCT assessment All FFR ≤ 0.75 and Vulnerable plaque will be treated. VP defined as TCFA ( cap thickness ≤ 75 micron); Ruptured plaque; or Plaque erosion with > 70 % AS or MLA < 2.5 mm2.
Intervention Type
Procedure
Intervention Name(s)
PCI revascularization strategy based FFR assessment
Intervention Description
PCI revascularization strategy based FFR assessment (all lesions with FFR≤0.80 will be treated)
Primary Outcome Measure Information:
Title
cardiac death, any myocardial infarction (MI) or any clinically-driven revascularization at 24 months
Description
cardiac death, any myocardial infarction (MI) or any clinically-driven revascularization at 24 months
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events in all lesions with a FFR between 0.76-0.80 left untreated in the experimental arm
Description
Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events in all lesions with a FFR between 0.76-0.80 left untreated in the experimental arm
Time Frame
24 months
Title
Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months
Description
Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months
Time Frame
24 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing PCI, aged 30-80 years with any clinical presentation Angiographic criteria: presence of ≥ 2 de novo target lesions* located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision) Angiographic criteria target lesion* (all criteria I-IV should be applicable): I. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation) *Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have ≥ 2 target lesions or one culprit and ≥ 1 target lesion. Exclusion Criteria: Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision) Lesion located in a grafted segment or in a vein graft In-stent restenosis lesions Left main trifurcation Left main lesion stand-alone (without other lesions) Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous) Chronic total occlusion Spontaneous coronary dissection Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years Patients with left ventricle (LV) function less than 30% Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5) Life expectancy less than 3 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jolanda Pol-van der Velde, MSc
Phone
+31 (0)38 426 2999
Email
jo.pol@diagram-zwolle.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elvin Kedhi, Prof.dr.
Organizational Affiliation
Director Innovation Clinic, Erasmus Academical Hospital, Université Libre de Bruxelles, Belgium and Silesian Medical University, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Different countries in Europe, Asia Pacific and Canada
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI Different PI's

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://diagramresearch.com/trials/
Description
Diagram B.V.

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COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

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