NCT04604197

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

30 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

October 21, 2020

Last Update Submit

February 12, 2026

Conditions

Coronary OcclusionLeft Main Coronary Artery DiseaseCoronary Artery StenosisCoronary DiseaseCoronary Artery Disease

Keywords

Angiography

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint: defined as : death, myocardial infarction, and stroke.

    Composite endpoint: defined as : death, myocardial infarction, and stroke.

    36 months

Secondary Outcomes (8)

  • All Death

    36 months

  • Cardiac Death

    36 months

  • Myocardial Infarction

    36 months

  • Stroke

    36 months

  • Stent thrombosis (ARC definite/probable)

    36 months

  • +3 more secondary outcomes

Study Arms (2)

Angiography and Clinical Follow up

EXPERIMENTAL

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

Clinical Follow up

ACTIVE COMPARATOR

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

Other: Clinical Follow up

Interventions

Angiography and Clinical Follow upOTHER

Angiography and Clinical Follow up

Angiography and Clinical Follow up
Clinical Follow upOTHER

Clinical Follow up

Clinical Follow up

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Hospital Universitario Regional de Malaga

Málaga, Malaga, 29010, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

Location

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

Location

Hospital General Universitario de Albacete

Albacete, 02006, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario San Juan de Alicante

Alicante, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitari Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

Location

Hospital General Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Hospital Universitario de León

León, 24071, Spain

Location

Hospital Universitario Lucus Agusti

Lugo, 27003, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (6)

  • Cavalcante R, Sotomi Y, Lee CW, Ahn JM, Farooq V, Tateishi H, Tenekecioglu E, Zeng Y, Suwannasom P, Collet C, Albuquerque FN, Onuma Y, Park SJ, Serruys PW. Outcomes After Percutaneous Coronary Intervention or Bypass Surgery in Patients With Unprotected Left Main Disease. J Am Coll Cardiol. 2016 Sep 6;68(10):999-1009. doi: 10.1016/j.jacc.2016.06.024.

    PMID: 27585503BACKGROUND

  • Puri R, de la Torre Hernandez JM, Auffret V. Routine Surveillance Coronary Angiography Post-PCI: Should We ReACT and Change Our Routine? JACC Cardiovasc Interv. 2017 Jan 23;10(2):118-120. doi: 10.1016/j.jcin.2016.11.020. Epub 2016 Dec 28. No abstract available.

    PMID: 28040444BACKGROUND

  • Aurigemma C, Burzotta F, Porto I, Niccoli G, Leone AM, Crea F, Trani C. Clinical impact of routine angiographic follow-up after percutaneous coronary interventions on unprotected left main. Cardiol J. 2018;25(5):582-588. doi: 10.5603/CJ.a2018.0092. Epub 2018 Aug 29.

    PMID: 30155864BACKGROUND

  • Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM 3rd, Taggart DP, 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 P, Bochenek A, Schampaert E, Page P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP; EXCEL Trial Investigators. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8;375(23):2223-2235. doi: 10.1056/NEJMoa1610227. Epub 2016 Oct 31.

    PMID: 27797291BACKGROUND

  • Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31.

    PMID: 27810312BACKGROUND

  • 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.

    PMID: 31562798BACKGROUND

MeSH Terms

Conditions

Coronary OcclusionCoronary Artery DiseaseCoronary StenosisCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 27, 2020

Study Start

April 16, 2021

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

ES(30)