Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
Purpose
To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.
Condition
- Percutaneous Coronary Intervention
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult patient ( ≥18 years old) presenting with CCS or NSTEACS with one or more study lesion(s) deemed appropriate (diameter stenosis 50-90%) for both pressure-wire and FFRangio physiologic assessment. General
Exclusion Criteria
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental FFRangio |
FFRangio guided revascularization |
|
|
Active Comparator Pressure wire |
Pressure wire-based guided revascularization (FFR or NHPR) |
|
Recruiting Locations
Medstar Union Memorial Hospital
Baltimore, Maryland 21218
Baltimore, Maryland 21218
MedStar Health Research Institute
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- CathWorks Ltd.
Detailed 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.