Trials / Active Not Recruiting

Active Not RecruitingNCT04604197

ANGiographic Evaluation of Left Main Coronary Artery INtErvention

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 400 (estimated)

Sponsor: Fundación EPIC · Academic / Other
Sex: All
Age: 18 Years – 85 Years
Healthy volunteers: Not accepted

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.

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.

Conditions

Interventions

Type	Name	Description
OTHER	Angiography and Clinical Follow up	Angiography and Clinical Follow up
OTHER	Clinical Follow up	Clinical Follow up

Timeline

Start date: 2021-04-16
Primary completion: 2026-03-01
Completion: 2026-04-01
First posted: 2020-10-27
Last updated: 2026-02-13

Locations

30 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT04604197. Inclusion in this directory is not an endorsement.