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
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Composite endpoint: defined as : death, myocardial infarction, and stroke. [ Time Frame: 36 months ]Composite endpoint: defined as : death, myocardial infarction, and stroke.
- All Death [ Time Frame: 36 months ]Occurrence of Death
- Cardiac Death [ Time Frame: 36 months ]Occurrence of Cardiac Death
- Myocardial Infarction [ Time Frame: 36 months ]Occurrence of Myocardial Infarction
- Stroke [ Time Frame: 36 months ]Occurrence of Stroke
- Stent thrombosis (ARC definite/probable) [ Time Frame: 36 months ]Occurrence of thrombosis (ARC definite/probable)
- Major bleeding event (BARC type 2-5) [ Time Frame: 36 months ]Occurrence of Major bleeding event (BARC type 2-5)
- Target Vessel revascularization. [ Time Frame: 36 months ]Occurrence of Target Vessel revascularization.
- Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention) [ Time Frame: 36 months ]Occurrence of New revascularization by CABG or PCI
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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|
- 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.
- 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.
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
|Contact: Iñigo Lozano, MD, PhDfirstname.lastname@example.org|
|Contact: Fundacion Epicemail@example.com|
|Responsible Party:||Fundación EPIC|
|Other Study ID Numbers:||
|First Posted:||October 27, 2020 Key Record Dates|
|Last Update Posted:||January 11, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Coronary Artery Disease
Arterial Occlusive Diseases