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Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL) (REVIVAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03283501
Recruitment Status : Unknown
Verified September 2017 by Enrico Cerrato, San Luigi Gonzaga Hospital.
Recruitment status was:  Recruiting
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Enrico Cerrato, San Luigi Gonzaga Hospital

Tracking Information
First Submitted Date September 4, 2017
First Posted Date September 14, 2017
Last Update Posted Date September 14, 2017
Actual Study Start Date April 20, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2017)
  • Evaluate the incidence of PCI after TAVI [ Time Frame: up to 5 year after TAVI implantation ]
    Evaluate the incidence of PCI after TAVI
  • Evaluate the clinical indications for PCI after TAVI [ Time Frame: intraoperative ]
    Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction
  • Evaluate the technical feasibility of PCI in patients with prior TAVI [ Time Frame: intraoperative ]
    Successful target coronary vessel revascularization
  • Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI [ Time Frame: up to 5 year after TAVI implantation ]
    outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)
Official Title A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis
Brief Summary Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.
Detailed Description

The increasing operator experience combined with an improved performance of devices have led to extend current transcatheter aortic valve implantation (TAVI) indications to patients at low or intermediate risk. The safety of TAVI in this population was initially tested in small observational studies and recently reported in the randomized PARTNER 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to surgery with respect to the primary endpoint of death or disabling stroke. In view of the changes in the TAVI population, including younger patients with longer survival, the number of patients that may require coronary revascularization after TAVI is expected to increase over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in patients previously treated with TAVI have been reported in small series.

Against this background, the purpose of this retrospective multicenter study is to evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

Objectives

  1. Evaluate the incidence of PCI after TAVI
  2. Evaluate the clinical indications for PCI after TAVI
  3. Evaluate the technical feasibility of PCI in patients with prior TAVI
  4. Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
Condition
  • Transcatheter Valve Implantation
  • TAVI
Intervention Procedure: PCI after TAVI
Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 12, 2017)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03283501
Other Study ID Numbers 001-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Enrico Cerrato, San Luigi Gonzaga Hospital
Study Sponsor San Luigi Gonzaga Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account San Luigi Gonzaga Hospital
Verification Date September 2017