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Coronary Artery Disease ProgressionREVASECNCT03349385

Registry of Secondary Revascularization

An observational study of Coronary Artery Disease Progression and Coronary Artery Disease of Significant Bypass Graft, run by Hospital San Carlos, Madrid at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study will evaluate patients with, at least, one previous procedure of coronary revascularization (surgical, percutaneous or both), that are referred for a new, clinically indicated, diagnostic coronary angiography, to describe their clinical characteristics, management, and prognosis, and will propose a… Read more about this study

Who is it for?
Ages 18 years and older
How many people
869 participants
Where
1 siteSpain
Study dates
22 Nov 2017to 15 Dec 2025
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography

Who may be able to join

  • Age ≥ 18 years
  • Previous successful coronary revascularization, either percutaneous or surgical, in at least one vessel with diameter ≥2 mm
  • Previous successful coronary revascularization must have been successful in at least one vessel and the patient must have been discharged after the previous revascularization
  • Clinically indicated diagnostic coronary angiography
  • Provide written informed consent

Who cannot join

  • Inability or refusal to provide written informed consent
  • Patient included in any other clinical trial in which the revascularization device is blind to patient or investigator, or is not commercially available
  • Insufficient data about previous revascularizations
  • Previous revascularization only on vessels of less than 2 mm or which was not successful in any vessel
  • Previous percutaneous revascularization with simple plain old balloon angioplasty
  • Index coronary angiography indicated as scheduled repeated angiography, planned percutaneous coronary intervention, or pre-surgical angiography

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28005

Other trials in Spain

About this study

Official title: Multicenter Registry of Secondary Revascularization

The study will evaluate patients with, at least, one previous procedure of coronary revascularization (surgical, percutaneous or both), that are referred for a new, clinically indicated, diagnostic coronary angiography, to describe their clinical characteristics, management, and prognosis, and will propose a prognosis-oriented classification.

Read the detailed description

Secondary or repeated revascularization refers to any repeated coronary intervention following an index coronary revascularization procedure, and represents a wide proportion of patients received in catheterization laboratories. These patients have an increased complexity and worse outcomes than patients without previous revascularization. Clinical investigation has focused in lesion-specific treatments when a single previous revascularization fails, but there is paucity of patient-level information including complex patients with multiple revascularizations. Other gaps in evidence addressed by this study are the absence of a a prognosis-oriented classification of previously revascularized patients and a clinical meaningful definition of revascularization failure. The registry as well intends to provide insights on how secondary revascularization decisions are taken and long term prognosis after secondary revascularization.

The registry of secondary revascularization (in Spanish: Registro multicéntrico de reVAscularización SECundaria, REVASEC) is a multicenter, prospective, observational cohort study that incudes consecutive patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography, in different Spanish hospitals. The aims are describing the incidence, clinical profile, therapeutic management and prognosis of these patients.

Keywords
Secondary revascularization, Repeat revascularization, Coronary revascularization, Coronary artery bypass graft
Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-oriented composite endpoint

    Composite endpoint including: all-cause death, any myocardial infarction or any new unplanned revascularization

    Measured: 1 year

Secondary outcomes (5)

  1. Rates of individual components of primary outcome

    Rates of individual components of primary outcomes: all-cause death, myocardial infarction or new unplanned revascularization

    Measured: 1 to 5 years

  2. Composite endpoint at 2 to 5 years

    Composite endpoint including: all-cause death, any myocardial infarction or new unplanned revascularization

    Measured: 2 to 5 years

  3. Rate of failure of previous revascularization

    Rate of failure of previous revascularization using the classical definition: >50% stent restenosis or >50% stenosis in a surgical graft

    Measured: baseline (assessed at index catheterization)

  4. Recurrent angina (CCS class, patients reported)

    Describe the presence of recurrent angina (CCS class) and analyze its predictors

    Measured: 1 to 5 years

  5. Feasibility of secondary revascularization

    Define the rates of successful and complete revascularization

    Measured: per protocol, 1 month after index catheterization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2017
  2. Study start22 Nov 2017
  3. Primary completion31 May 2021
  4. Study completion15 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
869 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03349385
Sponsor's protocol ID
ROV-EPI-2017-01
Acronym
REVASEC
Status last verified
Apr 2025
First submitted
11 Nov 2017
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Salinas P, Vilchez-Tschischke JP, Noriega F, Macaya F, Rosillo S, Garcia-Camarero T, de la Torre-Hernandez JM, de Tapia B, Jimenez-Kockar M, Regueiro A, Flores-Umanzor E, Garcia-Blas S, Gonzalez-D'Gregorio J, Gomez-Menchero AE, Diaz-Fernandez JF, Rondan J, Amat-Santos I, Ojeda S, Diez-Gil JL, de Miguel Castro A, Lozano Ruiz-Poveda F, Fernandez-Diaz JA, Manzano MC, Cruz-Gonzalez I, Pascual Tejerina V, Garcia Perez-Velasco J, Serra A, Poveda-Andres JL, Macaya C, Escaned J. Design and Rationale for a Real-World Prospective, Multicenter Registry of Myocardial Revascularization Failure and Secondary Revascularization: The REVASEC Study. Cardiovasc Revasc Med. 2022 Jul;40:50-56. doi: 10.1016/j.carrev.2021.11.015. Epub 2021 Nov 16.

    PubMed 34857473

  • Salinas P, Garcia-Camarero T, Jimenez-Kockar M, Regueiro A, Garcia-Blas S, Gomez-Menchero AE, Ojeda S, Vilchez-Tschischke JP, Amat-Santos I, Diez-Gil JL, Rondan J, Lozano Ruiz-Poveda F, de Miguel Castro A, Manzano MC, Pascual-Tejerina V, Cruz-Gonzalez I, Garcia Perez-Velasco J, Fernandez-Diaz JA, Escaned J; REVASEC working group (collaborators). Myocardial revascularization failure among patients requiring cardiac catheterization and secondary revascularization in contemporary clinical practice: Results of the REVASEC multicenter registry. Catheter Cardiovasc Interv. 2023 Oct;102(4):608-619. doi: 10.1002/ccd.30804. Epub 2023 Aug 15.

    PubMed 37582340

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease Progression and Coronary Artery Disease of Significant Bypass Graft, run by Hospital San Carlos, Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-oriented composite endpoint (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03349385, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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