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OpenTrials
Active, Not Recruiting

NCT Number: NCT03349385

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Progression Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Arteriosclerosis Coronary Artery Disease Coronary Artery Disease of Significant Bypass Graft Coronary Disease Heart Diseases Myocardial Ischemia Stent Restenosis Stent Stenosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinico San Carlos

Madrid, 28005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient-oriented composite endpoint

    Time frame: 1 year

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

Secondary outcomes

  1. Rates of individual components of primary outcome

    Time frame: 1 to 5 years

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

  2. Composite endpoint at 2 to 5 years

    Time frame: 2 to 5 years

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

  3. Rate of failure of previous revascularization

    Time frame: 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

  4. Recurrent angina (CCS class, patients reported)

    Time frame: 1 to 5 years

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

  5. Feasibility of secondary revascularization

    Time frame: per protocol, 1 month after index catheterization

    Define the rates of successful and complete revascularization

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Collaborators

  • Laboratorios Farmacéuticos Rovi, S.A.
  • S&H MEDICAL SCIENCE SERVICE, S.L.

Registry information

Official study title

Multicenter Registry of Secondary Revascularization

Acronym: REVASEC

Important dates

Study start
2017
Primary completion
2021
Study completion
2025
First posted
Nov 21, 2017
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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