REVASEC: Registry of Secondary Revascularization

Sponsor

Hospital San Carlos, Madrid (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03349385

Collaborator

Laboratorios Farmacéuticos Rovi, S.A. (Other), S&H MEDICAL SCIENCE SERVICE, S.L. (Other)

1,000

Enrollment

Locations

85.8

Anticipated Duration (Months)

500

Patients Per Site

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Progression Coronary Artery Disease of Significant Bypass Graft Stent Stenosis Stent Restenosis Coronary Arteriosclerosis

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multicenter Registry of Secondary Revascularization

Actual Study Start Date :

Nov 22, 2017

Actual Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

Jan 15, 2025

Outcome Measures

Primary Outcome Measures

Patient-oriented composite endpoint [1 year]
Composite endpoint including: all-cause death, any myocardial infarction or any new unplanned revascularization

Secondary Outcome Measures

Rates of individual components of primary outcome [1 to 5 years]
Rates of individual components of primary outcomes: all-cause death, myocardial infarction or new unplanned revascularization
Composite endpoint at 2 to 5 years [2 to 5 years]
Composite endpoint including: all-cause death, any myocardial infarction or new unplanned revascularization
Rate of failure of previous revascularization [baseline (assessed at index catheterization)]
Rate of failure of previous revascularization using the classical definition: >50% stent restenosis or >50% stenosis in a surgical graft
Recurrent angina (CCS class, patients reported) [1 to 5 years]
Describe the presence of recurrent angina (CCS class) and analyze its predictors
Feasibility of secondary revascularization [per protocol, 1 month after index catheterization]
Define the rates of successful and complete revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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