Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)
REVIVAL
A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis
1 other identifier
observational
500
2 countries
3
Brief Summary
Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2017
CompletedFirst Submitted
Initial submission to the registry
September 4, 2017
CompletedFirst Posted
Study publicly available on registry
September 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedSeptember 14, 2017
September 1, 2017
9 months
September 4, 2017
September 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Evaluate the incidence of PCI after TAVI
Evaluate the incidence of PCI after TAVI
up to 5 year after TAVI implantation
Evaluate the clinical indications for PCI after TAVI
Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction
intraoperative
Evaluate the technical feasibility of PCI in patients with prior TAVI
Successful target coronary vessel revascularization
intraoperative
Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI
outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure
up to 5 year after TAVI implantation
Interventions
Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
Eligibility Criteria
Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
You may qualify if:
- Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Humanitas Research Hospital, Humanitas University
Rozzano, Milan, Italy
Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
Turin, 10100, Italy
Hospital Clinico San Carlos
Madrid, Spain
Related Publications (1)
Stefanini GG, Cerrato E, Pivato CA, Joner M, Testa L, Rheude T, Pilgrim T, Pavani M, Brouwer J, Lopez Otero D, Munoz Garcia E, Barbanti M, Biasco L, Varbella F, Reimers B, Jimenez Diaz VA, Leoncini M, Salido Tahoces ML, Ielasi A, de la Torre Hernandez JM, Mylotte D, Garot P, Chieffo A, Nombela-Franco L; REVIVAL Investigators. Unplanned Percutaneous Coronary Revascularization After TAVR: A Multicenter International Registry. JACC Cardiovasc Interv. 2021 Jan 25;14(2):198-207. doi: 10.1016/j.jcin.2020.10.031.
PMID: 33478637DERIVED
Related Links
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 4, 2017
First Posted
September 14, 2017
Study Start
April 20, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
September 14, 2017
Record last verified: 2017-09