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Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
 
Region Sponsors
California - Northern
CathWorks Ltd.
 
Acronym KP IRB No.
2121311
 
Study Type Phase
Prospective Cohort Study with Direct Patient Contact
 
Study Population Description
 
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.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
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.
 
Exclusion Criteria
  • 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.

 
Keywords and/or Specific Medical Conditions
  • Cardiology
  • Surgery (Thoracic)
  • Surgery (General)
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
  • San Francisco Medical Center
 
Clinical Area
  • Cardiology
  • Surgery (General)
  • Surgery (Thoracic)


Principal Investigator:
Gopi Manthripragada
Contact Information:
- CTP Team
-CTPCollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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