Randomized ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2: Design and Rationale of the ISAR-CALC 2 Trial.
Clinical trial
Coronary artery calcification
Intravascular lithotripsy
Super high-pressure balloon
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
04 2023
04 2023
Historique:
received:
27
10
2022
revised:
30
11
2022
accepted:
22
12
2022
pubmed:
8
1
2023
medline:
22
3
2023
entrez:
7
1
2023
Statut:
ppublish
Résumé
The percutaneous treatment of severely calcified coronary lesions has been associated with lower performance of coronary stents and poor clinical long-term outcomes. Adequate lesion preparation before stent implantation is of paramount importance to minimize the risk of stent failure. Balloon-based techniques for lesion preparation have been the subject of numerous investigations, albeit comparative data from randomized trials are scarce. The ISAR-CALC 2 (ClinicalTrials.gov: NCT05072730) is an investigator-initiated, prospective, randomized, multicentre, assessors-blind, open-label trial designed to compare a lesion preparation strategy with either super high-pressure balloon or intravascular lithotripsy (IVL) before drug-eluting stent (DES) implantation in patients with severely calcified, undilatable coronary lesions. In total, 80 patients are required for trial completion. The primary endpoint will be final angiographic minimal lumen diameter (MLD) after stent implantation. Key secondary endpoints include stent expansion assessed by optical coherence tomography (OCT), procedural and strategy success, need for complementary lesion preparation with rotational atherectomy, acute lumen gain, and major adverse cardiac events up to 30-day follow-up. The ISAR-CALC 2 trial aims to demonstrate the superiority of a lesion preparation strategy with a super high-pressure balloon as compared with intravascular lithotripsy prior to DES implantation in patients with severely calcified undilatable coronary lesions.
Sections du résumé
BACKGROUND
The percutaneous treatment of severely calcified coronary lesions has been associated with lower performance of coronary stents and poor clinical long-term outcomes. Adequate lesion preparation before stent implantation is of paramount importance to minimize the risk of stent failure. Balloon-based techniques for lesion preparation have been the subject of numerous investigations, albeit comparative data from randomized trials are scarce.
STUDY DESIGN AND OBJECTIVES
The ISAR-CALC 2 (ClinicalTrials.gov: NCT05072730) is an investigator-initiated, prospective, randomized, multicentre, assessors-blind, open-label trial designed to compare a lesion preparation strategy with either super high-pressure balloon or intravascular lithotripsy (IVL) before drug-eluting stent (DES) implantation in patients with severely calcified, undilatable coronary lesions. In total, 80 patients are required for trial completion. The primary endpoint will be final angiographic minimal lumen diameter (MLD) after stent implantation. Key secondary endpoints include stent expansion assessed by optical coherence tomography (OCT), procedural and strategy success, need for complementary lesion preparation with rotational atherectomy, acute lumen gain, and major adverse cardiac events up to 30-day follow-up.
CONCLUSIONS
The ISAR-CALC 2 trial aims to demonstrate the superiority of a lesion preparation strategy with a super high-pressure balloon as compared with intravascular lithotripsy prior to DES implantation in patients with severely calcified undilatable coronary lesions.
Identifiants
pubmed: 36609101
pii: S1553-8389(22)00938-1
doi: 10.1016/j.carrev.2022.12.008
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT05072730']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
22-27Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Dr. Rheude has received speaker fees from SIS Medical and AstraZeneca. Dr. Joner reports institutional grant support from Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and Infraredx; consulting fees from Biotronik, TriCares, Veryan, and Shockwave; speaker fees from Abbott, AstraZeneca, Biotronik, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, Recor Medical and Shockwave; participation on a Steering Committee of Biotronik and Edwards Lifesciences; travel support from Boston Scientific, Cardiac Dimensions, Edwards Lifesciences and SIS Medical. Dr. Abdel-Wahab reports that his hospital received speaker honoraria and/or consulting fees on his behalf from Medtronic and Boston Scientific. Dr. Cassese reports lecture/proctoring honoraria from SIS Medical, AstraZeneca, Boston Scientific, and Teleflex; and grants to the institution from SIS Medical, Boston Scientific, Abiomed, and Abbott Vascular. All other authors have no relevant conflicts of interest to declare.