ANGiographic Evaluation of Left Main Coronary Artery INtErvention

NCT ID: NCT04604197

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2026-04-01

Brief Summary

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.

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.

Conditions

Coronary Occlusion; Left Main Coronary Artery Disease; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Angiography and Clinical Follow up

Intervention Type: OTHER

Angiography and Clinical Follow up

Clinical Follow up

After PCI. The patient is randomized to a Clinical Follow to 36 months

Group Type: ACTIVE_COMPARATOR

Clinical Follow up

Intervention Type: OTHER

Clinical Follow up

Interventions

Angiography and Clinical Follow up

Angiography and Clinical Follow up

Intervention Type: OTHER

Clinical Follow up

Clinical Follow up

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación EPIC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, Spain

Hospital Universitario de Cruces

Barakaldo, Bizkaia, Spain

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, Spain

Hospital Universitario Regional de Malaga

Málaga, Malaga, Spain

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, Spain

Hospital Universitario de A Coruña

A Coruña, , Spain

Hospital General Universitario de Albacete

Albacete, , Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Universitario San Juan de Alicante

Alicante, , Spain

Hospital Del Mar

Barcelona, , Spain

Hospital Universitari Vall D'Hebron

Barcelona, , Spain

Hospital Universitari Bellvitge

Barcelona, , Spain

Hospital Universitario de Ciudad Real

Ciudad Real, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Universitario de Cabueñes

Gijón, , Spain

Hospital Universitario Virgen de Las Nieves

Granada, , Spain

Hospital General Juan Ramón Jiménez

Huelva, , Spain

Hospital Universitario de León

León, , Spain

Hospital Universitario Lucus Agusti

Lugo, , Spain

Hospital Universitario La Princesa

Madrid, , Spain

Hospital Universitario Ramon Y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Virgen Arrixaca

Murcia, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

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Reference Type: BACKGROUND

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Stone GW, Kappetein AP, Sabik JF, Pocock SJ, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Brown WM 3rd, Lembo NJ, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman PE, Bochenek A, Schampaert E, Page P, Modolo R, Gregson J, Simonton CA, Mehran R, Kosmidou I, Genereux P, Crowley A, Dressler O, Serruys PW; EXCEL Trial Investigators. Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. N Engl J Med. 2019 Nov 7;381(19):1820-1830. doi: 10.1056/NEJMoa1909406. Epub 2019 Sep 28.

Reference Type: BACKGROUND

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Other Identifiers

EPIC23-ANGELINE

Identifier Type: -

Identifier Source: org_study_id