Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation (PRO-TAVI)

December 10, 2024 updated by: Michiel Voskuil, MD, PhD, UMC Utrecht

Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation: the PRO-TAVI Trial

The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
466

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • UMC Groningen
      • Utrecht, Netherlands, 3508GA
        • UMC Utrecht
    • Friesland
      • Leeuwarden, Friesland, Netherlands
        • Medisch Centrum Leeuwarden
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Radboudumc
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastricht UMC+
    • Noord-Brabant
      • Breda, Noord-Brabant, Netherlands
        • Amphia Ziekenhuis Breda
      • Eindhoven, Noord-Brabant, Netherlands
        • Catharina Ziekenhuis Eindhoven
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
        • Amsterdam UMC
      • Amsterdam, Noord-Holland, Netherlands
        • OLVG
    • Overijssel
      • Enschede, Overijssel, Netherlands
        • Medisch Spectrum Twente
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands
        • Antonius Ziekenhuis Nieuwegein
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands
        • Haga Ziekenhuis Den Haag

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Severe AoS meeting the criteria stated by the ESC in the ESC/EACTS Guidelines for the management of valvular heart disease AND considered symptomatic (NYHA functional class ≥ 2);
  • TAVI decided by multidisciplinary Heart Team taken into account the international standards by ESC and guidelines of Dutch Society for Cardiology (NVVC);
  • ≥ 1 stenosis in epicardial coronary artery (> 2.5mm) or bypass graft. Stenosis is considered significant if angiographic 70-99% or angiographic 40-70% with positive hemodynamic parameters.
  • Written informed consent.

Exclusion Criteria:

  • Unprotected LM-stenosis or equivalent
  • No PCI-eligible stenosis
  • Contraindication for DAPT
  • Life expectancy < 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TAVI without routine PCI
Patients who are randomized to the experimental or index group undergo TAVI without routine PCI
Procedure: No PCI
Omission of PCI of significant coronary artery disease prior to TAVI
No Intervention: TAVI with routine PCI
Patients who are randomized to the control or reference group undergo TAVI with routine PCI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria
Time Frame: 12 months from randomization
12 months from randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Left ventricular function measured by echocardiography
Time Frame: 12 months
12 months
Cost-effectiveness of omission of PCI using QALYs
Time Frame: 4 months - 12 months
4 months - 12 months
Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios
Time Frame: 4 months - 12 months
4 months - 12 months
Quality of life assessed by Euro Quality of Life 5D Questionnaire
Time Frame: 4 months - 12 months
the system produces a 5-digit health status profile to describe quality of life in a descriptive manner. Therefore, no lowest and highest value can be stated.
4 months - 12 months
Quality of life assessed by SF-36 Questionnaire
Time Frame: 4 months - 12 months
Questionnaire consists of eight sections. Each section is transformed into a 0 - 100 scale. The lower the score the more disability.
4 months - 12 months
Composite of all-cause mortality, myocardial infarction, stroke, in accordance with VARC-3 criteria
Time Frame: 4 months - 12 months - total follow up 5 years
4 months - 12 months - total follow up 5 years
all-cause mortality
Time Frame: 4 months - 12 months - total follow up 5 years
VARC-3
4 months - 12 months - total follow up 5 years
myocardial infarction
Time Frame: 4 months - 12 months - total follow up 5 years
VARC-3
4 months - 12 months - total follow up 5 years
stroke
Time Frame: 4 months - 12 months - total follow up 5 years
VARC-3
4 months - 12 months - total follow up 5 years
VARC-3 bleeding
Time Frame: 4 months - 12 months - total follow up 5 years
4 months - 12 months - total follow up 5 years
BARC bleeding
Time Frame: 4 months - 12 months - total follow up 5 years
BARC bleeding > type 1
4 months - 12 months - total follow up 5 years
urgent and elective revascularization
Time Frame: 4 months - 12 months - total follow up 5 years
ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials & ARC-2
4 months - 12 months - total follow up 5 years
Target lesion revascularization
Time Frame: 4 months - 12 months - total follow up 5 years
ARC-2
4 months - 12 months - total follow up 5 years
Target vessel revascularization
Time Frame: 4 months - 12 months - total follow up 5 years
ARC-2
4 months - 12 months - total follow up 5 years
rehospitalization
Time Frame: 4 months - 12 months - total follow up 5 years
VARC-3
4 months - 12 months - total follow up 5 years
Anginal status (CCS)
Time Frame: 4 months - 12 months
4 months - 12 months
NYHA classification
Time Frame: 4 months - 12 months
4 months - 12 months
Acute kidney injury stage 3 and 4
Time Frame: 4 months - 12 months - total follow up 5 years
VARC-3
4 months - 12 months - total follow up 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UMC Utrecht

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michiel Voskuil, MD PhD, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL77915.041.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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