ANGiographic Evaluation of Left Main Coronary Artery INtErvention (ANGELINE)

February 12, 2026 updated by: Fundación EPIC
To assess if an angiographic follow-up at 6 months after Percutaneous Coronary Intervention in Left Main Coronary Artery Disease decrease the composite objective of death, myocardial infarction, and stroke at 36 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Percutaneous coronary intervention (PCI) with drug-eluting stents in left main (LM) disease has demonstrated similar results than surgical revascularization in patients with SYNTAX score < 33, being the main drawback of PCI a higher rate of new revascularization. A small study found a reduction in the composite end-point of cardiac death, myocardial infarction and urgent revascularization with a routine angiographic follow-up. The investigators have designed a prospective, randomized, controlled, two-arm multicenter study in patients aged 18-85 with LM disease and SYNTAX score <33 and in cases ≥ 33 based on the Heart Team decision to assess the benefit of a routine angiographic follow-up 6 months after LM stenting. After the index procedure and before hospital discharge the patient will be randomized to routine invasive angiographic follow-up at 6 months plus clinical follow-up at 6 months, 1, 2 and 3 years vs. the control arm, which would be followed clinically at 6 months, 1, 2 and 3 years. Based on our calculations, an adequately powered trial would require 1009 patients per arm but due to the uncertainty of the results and the current economical restrictions we have designed a pilot study in 400 patients to find out the convenience of an adequately powered trial. All the lesions should be treated with an everolimus eluting stent with permanent fluoropolymer. It will be desirable to achieve complete revascularization and it will be highly recommended to perform the procedures guided with an intravascular image technique (OCT or IVUS (IntraVascular UltraSound) according to operator´s criteria). The main outcome will be death, myocardial infarction and cerebrovascular accident at 3 years. The initial percutaneous technique and the decision about the convenience and way of revascularization in case of restenosis in the follow-up will be left at the operator´s discretion, according in the most adequate way to the current guidelines. Nonetheless, the investigators are strongly encouraged to rely on intravascular techniques, based on either imaging or physiology. In those cases with in-stent hyperplasia with doubts about possible restenosis, FFR and RFR (Resting full-cycle ratio) will be performed, with low threshold to achieve a high rate of ruling out the restenosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario de A Coruna
      • Albacete, Spain, 02006
        • Hospital General Universitario de Albacete
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Alicante, Spain
        • Hospital Universitario San Juan de Alicante
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08907
        • Hospital Universitari Bellvitge
      • Ciudad Real, Spain, 13005
        • Hospital Universitario de Ciudad Real
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Gijón, Spain, 33394
        • Hospital Universitario de Cabuenes
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de Las Nieves
      • Huelva, Spain, 21005
        • Hospital General Juan Ramon Jimenez
      • León, Spain, 24071
        • Hospital Universitario de Leon
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Agustí
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen Arrixaca
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Universitario de Santiago de Compostela
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valladolid, Spain, 47003
        • Hospital Clinico Universitario de Valladolid
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Hospital Universitario de Cruces
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Hospital Universitario Donostia
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Hospital Universitario Regional de Málaga
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital Galdakao-Usansolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18- 85 years at the date of the PCI.
  • With PCI for presenting de novo lesions in the Left Main Artery by implanting a cobalt-chrome stent with everolimus-eluting fluoropolymer.
  • Informed consent signed.

Exclusion Criteria:

  • Refusal to participate in the study.
  • Patients with left main disease who have been admitted with STEMI and have undergone primary angioplasty in a culprit lesion different than the left main. The left main lesion has been treated as a stage procedure and discharged with left ventricular ejection fraction < 35 %.
  • Previous coronary surgery.
  • Creatinine clearance <40 ml / min.
  • Contraindication for double antiaggregation after PCI.
  • Patients life expectancy <36 months.
  • Included in other studies or clinical trials.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Angiography and Clinical Follow up
After PCI. The patient is randomized to an angiographic follow-up at 6 months and a Clinical Follow to 36 months
Other: Angiography and Clinical Follow up
Angiography and Clinical Follow up
Active Comparator: Clinical Follow up
After PCI. The patient is randomized to a Clinical Follow to 36 months
Other: Clinical Follow up
Clinical Follow up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite endpoint: defined as : death, myocardial infarction, and stroke.
Time Frame: 36 months
Composite endpoint: defined as : death, myocardial infarction, and stroke.
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All Death
Time Frame: 36 months
Occurrence of Death
36 months
Cardiac Death
Time Frame: 36 months
Occurrence of Cardiac Death
36 months
Myocardial Infarction
Time Frame: 36 months
Occurrence of Myocardial Infarction
36 months
Stroke
Time Frame: 36 months
Occurrence of Stroke
36 months
Stent thrombosis (ARC definite/probable)
Time Frame: 36 months
Occurrence of thrombosis (ARC definite/probable)
36 months
Major bleeding event (BARC type 2-5)
Time Frame: 36 months
Occurrence of Major bleeding event (BARC type 2-5)
36 months
Target Vessel revascularization.
Time Frame: 36 months
Occurrence of Target Vessel revascularization.
36 months
Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention)
Time Frame: 36 months
Occurrence of New revascularization by CABG or PCI
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPIC23-ANGELINE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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