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Active, not recruitingNCT03349385REVASECUpdated Apr 24, 2025

Registry of Secondary Revascularization

An observational study in Coronary Artery Disease Progression, Coronary Artery Disease of Significant Bypass Graft and Stent Stenosis, sponsored by Hospital San Carlos, Madrid. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.

Sponsored by Hospital San Carlos, Madrid · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
869
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Secondary revascularization
  • Repeat revascularization
  • Coronary revascularization
  • Coronary artery bypass graft
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
869 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Patient-oriented composite endpoint

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

    Time frame: 1 year

Secondary outcomes

  1. Rates of individual components of primary outcome

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

    Time frame: 1 to 5 years

  2. Composite endpoint at 2 to 5 years

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

    Time frame: 2 to 5 years

  3. 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

    Time frame: baseline (assessed at index catheterization)

  4. Recurrent angina (CCS class, patients reported)

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

    Time frame: 1 to 5 years

  5. Feasibility of secondary revascularization

    Define the rates of successful and complete revascularization

    Time frame: per protocol, 1 month after index catheterization

06

Study locations

1 site
  • Hospital Clinico San Carlos
    Madrid, 28005, Spain
07

References and documents

Publications

  • 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. PubMed 34857473 ↗
  • 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. PubMed 37582340 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03349385
Lead sponsor
Hospital San Carlos, Madrid
Collaborators
Laboratorios Farmacéuticos Rovi, S.A., S&H MEDICAL SCIENCE SERVICE, S.L.
Responsible party
Pablo Salinas (MD, Hospital San Carlos, Madrid) — Principal investigator
First posted
Nov 21, 2017
Start date
Nov 22, 2017
Primary completion
May 31, 2021
Completion
Dec 15, 2025 (estimated)
Last update
Apr 24, 2025

Study contacts

Pablo Salinas, MD, PhD
principal investigator · Hospital San Carlos, Madrid

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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