Registry of Secondary Revascularization

Active, not recruiting

• Conditions: Coronary Artery Disease Progression; Stent Restenosis; Coronary Arteriosclerosis; Stent Stenosis; Coronary Artery Disease of Significant Bypass Graft

• Registration Number: NCT03349385
• Lead Sponsor: Hospital San Carlos, Madrid

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.

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 Timeline

• Study First Submitted: 2017-11-11
• Study First Submitted QC: 2017-11-19
• Study First Posted: 2017-11-21
• Study Start: 2017-11-22
• Primary Completion: 2021-05-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 869

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Recurrent angina (CCS class, patients reported)	1 to 5 years	Describe the presence of recurrent angina (CCS class) and analyze its predictors
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
Feasibility of secondary revascularization	per protocol, 1 month after index catheterization	Define the rates of successful and complete revascularization

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain