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Evaluation of the present pressure criteria for a patient to undergo coronary stenting

COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENion to Reduce Cardiovascular Events COMBINE-INTERVENE trial. Acronym COMBINE-INTERVENE - COMBINE-INTERVENE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044996
Enrollment
1222
Registered
2022-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I21- Acute myocardial infarction Health Condition 2: I20- Angina pectoris Health Condition 3: I23- Certain current complications following ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction (within the 28 day period) Health Condition 4: I23- Certain current complications following ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction (within the 28 day period) Health Condition 5: I24- Other acute ischemic heart diseases Health Con

Interventions

Intervention1: Percutaneous Coronary Intervention: To intervene in patients with FFR less than or equal to 0.75, and in those with FFR more than 0.75 and OCT showing vulnerable plaque morphology durin

Sponsors

Diagram BV
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing PCI with any clinical presentation 2. At least 2 de novo target lesions located in 2 different native coronary arteries feasible for treatment 3. Diameter Stenosis >50% 4. The de novo lesion located in native (non-grafted) vessel 5. TIMI 3 flow in all vessels (except culprit lesions in patietns with myocardial infarction)

Exclusion criteria

Exclusion criteria: 1. Multi-vessel disease requiring CABG treatment 2. Lesion in a grafted segment or vein graft 3. In-stent restenosis 4. Left main trifurcation 5. Left main lesion stand-alone 6. Severe tortuous lesions such that FFR and OCT judged impossible/dangerous 7. Chronic total occlusion

Design outcomes

Secondary

MeasureTime frame
Define cut-off of severe ischemia with FFRTimepoint: Date of procedure, 1 year and 2 years—

Primary

MeasureTime frame
To prove that in patients with multivessel coronary disease (MVD) a PCI revascularization strategy based on revascularisation of all lesions presenting a vulnerable plaque morphology & severe ischemic lesions (FFRââ?°Â¤ 0.75) is superior to ischemia-guided (fractional flow reserve (FFR)-guided) only PCI revascularization.Timepoint: Date of procedure, 1 year and 2 years—

Countries

India, Netherlands, Romania

Contacts

Public ContactSamman Verma

PGIMER, Chandigarh

samman.verma93@gmail.com7347381496

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026