Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment (ALL-RISE)

CathWorks

Status: Active, not recruiting

Conditions: Percutaneous Coronary Intervention

Treatments: Device: FFR or NHPR; Device: FFRangio

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05893498

CathWorks CWX-08

Details and patient eligibility

About

To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.

Full description

ALL-RISE is a prospective, randomized, multi-center, controlled post-market study. The ALL-RISE study is designed to test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease being evaluated for percutaneous coronary intervention (PCI) with respect to major adverse cardiac events (MACE) at one year.

Enrollment: 1,924 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Adult patients (≥18 years of age) with one or more study lesion(s) (diameter stenosis 50-90%) deemed appropriate for both pressure-wire and FFRangio physiologic assessment.

General Exclusion Criteria:

1. Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment
2. Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s)
3. Patients undergoing coronary physiologic assessment where one possible outcome is referral for CABG
4. The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
5. Severe left sided valvular heart disease
6. Most recent documented LVEF ≤30%
7. Women who are pregnant or breastfeeding (women of childbearing potential are required to have negative pregnancy test within 1 week of index procedure)
8. Patients with life expectancy <1 year life as estimated by treating physician.
9. Subjects enrolled in other ongoing non-registry clinical studies that would impact conduct or outcomes of this study (registries and long-term follow-up of other studies are allowed)
10. Subjects who have undergone angiographic or wire-based coronary physiological assessment for 1 or more potential study lesions within 30 days of enrollment.

Angiographic Exclusion Criteria:

1. Coronary angiogram is not acquired per instructions as defined in the Study Protocol
2. Sthe study lesion is the clear culprit for a NSTEACS
3. Angiographic evidence of a procedural complication (e.g., acute stent thrombosis, flow-limiting dissection, perforation, slow/no reflow, or other) prior to randomization
4. Thrombolysis in myocardial infarction (TIMI) Grade 2 flow or lower in any study vessel at time of enrollment
5. The study vessel is in a left coronary vessel with separate left anterior descending and left circumflex ostia arising from the aorta
6. The study lesion involves the left main coronary artery (stenosis ≥ 50%)
7. The study lesion is in an ectatic or aneurysmal coronary segment (defined as lumen diameter 1.5x diameter or the reference vessel)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,924 participants in 2 patient groups

FFRangio

Experimental group

Description:

FFRangio guided revascularization

Treatment:

Device: FFRangio

Pressure wire

Active Comparator group

Description:

Pressure wire-based guided revascularization (FFR or NHPR)

Treatment:

Device: FFR or NHPR