Registry of Secondary Revascularization

Coronary Arteriosclerosis Clinical Trial

— REVASEC  

Official title:

Multicenter Registry of Secondary Revascularization

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03349385
• Other study ID #: ROV-EPI-2017-01
• Status: Active, not recruiting
• Start date: November 22, 2017
• Est. completion date: January 15, 2025

Study information

• Verified date: November 2023
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 prognosis-oriented classification.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 869
• Est. completion date: January 15, 2025
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid	Laboratorios Farmacéuticos Rovi, S.A., S&H MEDICAL SCIENCE SERVICE, S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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, — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-oriented composite endpoint	Composite endpoint including: all-cause death, any myocardial infarction or any new unplanned revascularization	1 year
Secondary	Rates of individual components of primary outcome	Rates of individual components of primary outcomes: all-cause death, myocardial infarction or new unplanned revascularization	1 to 5 years
Secondary	Composite endpoint at 2 to 5 years	Composite endpoint including: all-cause death, any myocardial infarction or new unplanned revascularization	2 to 5 years
Secondary	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	baseline (assessed at index catheterization)
Secondary	Recurrent angina (CCS class, patients reported)	Describe the presence of recurrent angina (CCS class) and analyze its predictors	1 to 5 years
Secondary	Feasibility of secondary revascularization	Define the rates of successful and complete revascularization	per protocol, 1 month after index catheterization