ANGELINE: ANGiographic Evaluation of Left Main Coronary Artery INtErvention

Sponsor
Fundación EPIC (Other)
Overall Status
Recruiting
CT.gov ID
NCT04604197
Collaborator
(none)
400
Enrollment
28
Locations
2
Arms
55.5
Anticipated Duration (Months)
14.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Angiography and Clinical Follow up
  • Other: Clinical Follow up
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ANGiographic Evaluation of Left Main Coronary Artery INtErvention
Actual Study Start Date :
Apr 16, 2021
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

ArmIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Composite endpoint: defined as : death, myocardial infarction, and stroke. [36 months]

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

Secondary Outcome Measures

  1. All Death [36 months]

    Occurrence of Death

  2. Cardiac Death [36 months]

    Occurrence of Cardiac Death

  3. Myocardial Infarction [36 months]

    Occurrence of Myocardial Infarction

  4. Stroke [36 months]

    Occurrence of Stroke

  5. Stent thrombosis (ARC definite/probable) [36 months]

    Occurrence of thrombosis (ARC definite/probable)

  6. Major bleeding event (BARC type 2-5) [36 months]

    Occurrence of Major bleeding event (BARC type 2-5)

  7. Target Vessel revascularization. [36 months]

    Occurrence of Target Vessel revascularization.

  8. Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention) [36 months]

    Occurrence of New revascularization by CABG or PCI

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  • Myocardial infarction with ST-segment elevation on current admission.

  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hospital Universitario de CrucesBarakaldoBizkaiaSpain48903
2Hospital Universitario DonostiaDonostiaGipuzkoaSpain20014
3Hospital Universitario Regional de MalagaMálagaMalagaSpain29010
4Hospital Galdakao-UsansoloGaldakaoVizcayaSpain48960
5Hospital General Universitario de AlbaceteAlbaceteSpain02006
6Hospital General Universitario de AlicanteAlicanteSpain03010
7Hospital Universitario San Juan de AlicanteAlicanteSpain
8Hospital Del MarBarcelonaSpain08003
9Hospital Universitari Vall D'HebronBarcelonaSpain08035
10Hospital Universitari BellvitgeBarcelonaSpain08907
11Hospital Universitario de Ciudad RealCiudad RealSpain13005
12Hospital Universitario de A CoruñaCoruñaSpain15006
13Hospital Universitario Reina SofiaCórdobaSpain14004
14Hospital Universitario de CabueñesGijónSpain33394
15Hospital Universitario Virgen de Las NievesGranadaSpain18014
16Hospital General Juan Ramón JiménezHuelvaSpain21005
17Hospital Universitario de LeónLeónSpain24071
18Hospital Universitario La PrincesaMadridSpain28006
19Hospital Universitario Ramon Y CajalMadridSpain28034
20Hospital Universitario 12 de OctubreMadridSpain28041
21Hospital Universitario La PazMadridSpain28046
22Hospital Universitario Virgen ArrixacaMurciaSpain30120
23Hospital Universitario Marques de ValdecillaSantanderSpain39008
24Hospital Clínico Universitario de Santiago de CompostelaSantiago De CompostelaSpain15706
25Hospital Clinico Universitario de ValenciaValenciaSpain46010
26Hospital Clinico Universitario de ValladolidValladolidSpain47003
27Hospital Clinico Universitario Lozano BlesaZaragozaSpain50009
28Hospital Universitario Miguel ServetZaragozaSpain50009

Sponsors and Collaborators

  • Fundación EPIC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fundación EPIC
ClinicalTrials.gov Identifier:
NCT04604197
Other Study ID Numbers:
  • EPIC23-ANGELINE
First Posted:
Oct 27, 2020
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundación EPIC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2022