ANGELINE: ANGiographic Evaluation of Left Main Coronary Artery INtErvention

Sponsor

Fundación EPIC (Other)

Overall Status

Recruiting

CT.gov ID

NCT04604197

Collaborator

(none)

400

Enrollment

Locations

Arms

55.5

Anticipated Duration (Months)

13.3

Patients Per Site

0.2

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 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	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

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

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

Primary Outcome Measures

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

Secondary Outcome Measures

All Death [36 months]
Occurrence of Death
Cardiac Death [36 months]
Occurrence of Cardiac Death
Myocardial Infarction [36 months]
Occurrence of Myocardial Infarction
Stroke [36 months]
Occurrence of Stroke
Stent thrombosis (ARC definite/probable) [36 months]
Occurrence of thrombosis (ARC definite/probable)
Major bleeding event (BARC type 2-5) [36 months]
Occurrence of Major bleeding event (BARC type 2-5)
Target Vessel revascularization. [36 months]
Occurrence of Target Vessel revascularization.
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:

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

	Site	City	State	Country	Postal Code
1	Hospital Universitari Germans Trias I Pujol	Badalona	Barcelona	Spain	08916
2	Hospital Universitario de Cruces	Barakaldo	Bizkaia	Spain	48903
3	Hospital Universitario Donostia	Donostia	Gipuzkoa	Spain	20014
4	Hospital Universitario Regional de Malaga	Málaga	Malaga	Spain	29010
5	Hospital Galdakao-Usansolo	Galdakao	Vizcaya	Spain	48960
6	Hospital General Universitario de Albacete	Albacete		Spain	02006
7	Hospital General Universitario de Alicante	Alicante		Spain	03010
8	Hospital Universitario San Juan de Alicante	Alicante		Spain
9	Hospital Del Mar	Barcelona		Spain	08003
10	Hospital Universitari Vall D'Hebron	Barcelona		Spain	08035
11	Hospital Universitari Bellvitge	Barcelona		Spain	08907
12	Hospital Universitario de Ciudad Real	Ciudad Real		Spain	13005
13	Hospital Universitario de A Coruña	Coruña		Spain	15006
14	Hospital Universitario Reina Sofia	Córdoba		Spain	14004
15	Hospital Universitario de Cabueñes	Gijón		Spain	33394
16	Hospital Universitario Virgen de Las Nieves	Granada		Spain	18014
17	Hospital General Juan Ramón Jiménez	Huelva		Spain	21005
18	Hospital Universitario de León	León		Spain	24071
19	Hospital Universitario Lucus Agusti	Lugo		Spain	27003
20	Hospital Universitario La Princesa	Madrid		Spain	28006
21	Hospital Universitario Ramon Y Cajal	Madrid		Spain	28034
22	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
23	Hospital Universitario La Paz	Madrid		Spain	28046
24	Hospital Universitario Virgen Arrixaca	Murcia		Spain	30120
25	Hospital Universitario Marques de Valdecilla	Santander		Spain	39008
26	Hospital Clínico Universitario de Santiago de Compostela	Santiago De Compostela		Spain	15706
27	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
28	Hospital Clinico Universitario de Valladolid	Valladolid		Spain	47003
29	Hospital Clinico Universitario Lozano Blesa	Zaragoza		Spain	50009
30	Hospital Universitario Miguel Servet	Zaragoza		Spain	50009