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

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ClinicalTrials.gov Identifier: NCT03283501
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Enrico Cerrato, San Luigi Gonzaga Hospital

Brief Summary:
Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

Condition or disease Intervention/treatment
Transcatheter Valve Implantation TAVI Procedure: PCI 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
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Intervention Details:
  • 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


Primary Outcome Measures :
  1. Evaluate the incidence of PCI after TAVI [ Time Frame: up to 5 year after TAVI implantation ]
    Evaluate the incidence of PCI after TAVI

  2. 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

  3. Evaluate the technical feasibility of PCI in patients with prior TAVI [ Time Frame: intraoperative ]
    Successful target coronary vessel revascularization

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283501


Locations
Italy
Humanitas Research Hospital, Humanitas University Recruiting
Rozzano, Milan, Italy
Contact: Giulio Stefanini, MD, PhD    +390282241    giulio.stefanini@hunimed.eu   
Principal Investigator: Giulio Stefanini, MD,PhD         
Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy Recruiting
Turin, Italy, 10100
Contact: Enrico Cerrato, MD    +390119026602    enrico.cerrato@gmail.com   
Principal Investigator: Enrico Cerrato, MD         
Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain
Contact: Luis Nombela-Franco, MD,PhD    +34 91 330 30 00    luisnombela@yahoo.com   
Principal Investigator: Luis Nombela-Franco, MD, PhD         
Sponsors and Collaborators
San Luigi Gonzaga Hospital

Additional Information:
Responsible Party: Enrico Cerrato, Principal Investigator, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier: NCT03283501     History of Changes
Other Study ID Numbers: 001-2017
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enrico Cerrato, San Luigi Gonzaga Hospital:
TAVI
PCI