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| Overall Recruitment Status: Active, currently enrolling |
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| Official Title |
| Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment |
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
NCT No. |
| ALLRISE |
NCT05893498 |
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| Study Type |
Phase |
| OBSERVATIONAL |
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| Purpose |
| 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. |
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| Detailed Description |
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- 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.
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- General Exclusion Criteria:
Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment
Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s)
Patients undergoing coronary physiologic assessment prior to possible CABG.
The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
Severe left sided valvular heart disease
LVEF = 30%
Women who are pregnant or breastfeeding
Patients with life expectancy <1 year life as estimated by treating physician.
Subjects enrolled in other ongoing clinical studies.
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
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