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Trial record 1 of 1 for:    ANGELINE
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ANGiographic Evaluation of Left Main Coronary Artery INtErvention (ANGELINE)

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ClinicalTrials.gov Identifier: NCT04604197
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
Fundación EPIC

Study Description
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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 disease Intervention/treatment Phase
Coronary Occlusion Left Main Coronary Artery Disease Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Other: Angiography and Clinical Follow up Other: Clinical Follow up Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 16, 2021
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/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
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Primary Outcome Measures :
  1. Composite endpoint: defined as : death, myocardial infarction, and stroke. [ Time Frame: 36 months ]
    Composite endpoint: defined as : death, myocardial infarction, and stroke.


Secondary Outcome Measures :
  1. All Death [ Time Frame: 36 months ]
    Occurrence of Death

  2. Cardiac Death [ Time Frame: 36 months ]
    Occurrence of Cardiac Death

  3. Myocardial Infarction [ Time Frame: 36 months ]
    Occurrence of Myocardial Infarction

  4. Stroke [ Time Frame: 36 months ]
    Occurrence of Stroke

  5. Stent thrombosis (ARC definite/probable) [ Time Frame: 36 months ]
    Occurrence of thrombosis (ARC definite/probable)

  6. Major bleeding event (BARC type 2-5) [ Time Frame: 36 months ]
    Occurrence of Major bleeding event (BARC type 2-5)

  7. Target Vessel revascularization. [ Time Frame: 36 months ]
    Occurrence of Target Vessel revascularization.

  8. Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention) [ Time Frame: 36 months ]
    Occurrence of New revascularization by CABG or PCI


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604197


Contacts
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Contact: Iñigo Lozano, MD, PhD +34987876135 ilozano@fundacionepic.org
Contact: Fundacion Epic +34987876135 iepic@fundacionepic.org

Locations
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Sponsors and Collaborators
Fundación EPIC
More Information
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Publications:
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. Erratum In: Lancet. 2016 Dec 3;388(10061):2742.

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Responsible Party: Fundación EPIC
ClinicalTrials.gov Identifier: NCT04604197    
Other Study ID Numbers: EPIC23-ANGELINE
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación EPIC:
Angiography
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Coronary Occlusion
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases