Registry of Secondary Revascularization

NCT ID: NCT03349385

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

869 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-22

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease Progression Coronary Artery Disease of Significant Bypass Graft Stent Stenosis Stent Restenosis Coronary Arteriosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratorios Farmacéuticos Rovi, S.A.

UNKNOWN

Sponsor Role collaborator

S&H MEDICAL SCIENCE SERVICE, S.L.

OTHER

Sponsor Role collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Pablo Salinas

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pablo Salinas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Carlos, Madrid

Locations

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Hospital Clinico San Carlos

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 34857473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37582340 (View on PubMed)

Other Identifiers

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ROV-EPI-2017-01

Identifier Type: -

Identifier Source: org_study_id

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