PCI Revascularization Strategies for Coronary Artery Disease

Recruiting in Palo Alto (17 mi)

+49 other locations

Overseen byElvin Kedhi, Prof.dr.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Diagram B.V.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals aged 30-80 with multiple vessel coronary artery disease who are undergoing PCI. They must have at least two new blockages in different arteries suitable for PCI, as determined by a heart team. The blockages should be significant but the blood flow through them must still be normal.

Inclusion Criteria

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)

I am between 30 and 80 years old and am having a PCI procedure.

I have at least 2 target lesions or 1 culprit and 1 target lesion for FFR.

+1 more

Participant Groups

The COMBINE-INTERVENE Trial is testing if using both FFR (a pressure wire test) and OCT (an imaging test) to guide where stents should go during PCI is better than just using FFR alone in patients with multiple blocked arteries.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessmentExperimental Treatment1 Intervention

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

Group II: MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)Placebo Group1 Intervention

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