Coronary Artery Disease, Cutting Balloon, Percutaneous Coronary Intervention
Conditions
Brief summary
Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. Notwithstanding, stent-related events yet occur. Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions
Detailed description
The study will be a prospective, multicenter, randomized controlled trial in patients undergoing PCI with the novo coronary disease. A total of 96 patients with de novo coronary artery stenosis will be included. After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Random allocation in a 1:1 fashion to one of the following strategies: A) Study group: Pre-dilation with cutting balloon followed by ASES implantation. B) Control group: Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation. Stent optimisation will be performed based on intracoronary imaging findings.
Interventions
DEVICEPredilation with cutting balloon.
PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon.
DEVICEPredilation with conventional balloon
PCI will be performed under OCT guidance. Predilation of the lesion will be done with conventional balloon (semi-compliant or non-compliant)
Sponsors
Hospital Universitario La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses \>50% in a native coronary artery.
Exclusion criteria
1. Cardiogenic shock 2. Patients presenting with ST-segment elevation myocardial infarction 3. Patients undergoing chronic total occlusions PCI 4. Patients undergoing left main PCI 5. Patients undergoing venous bypass graft lesions PCI 6. Patients with in-stent restenosis 7. Inability to provide informed consent 8. Life expectancy \<1year due to non-cardiac disease 9. Currently participating in another trial before reaching first endpoint There will be no exclusion based on mode of co-morbidities, left ventricular function, number of diseased vessels and lesions, or number of target lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum stent area post-stenting measured by optimal coherence tomography (OCT) | Immediately after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean stent area measured by optimal coherence tomography | 9 month follow-up. | — |
| Acute procedural success | Immediately after the procedure | — |
| Coronary disection | Immediately after the procedure | — |
| Malapposition (Major/minor) post-stenting measured by optimal coherence tomography | Immediately after the procedure and at 9 month follow-up | — |
| Mean neointimal hyperplasia area measured by optimal coherence tomography | 9 months | — |
| Minimum stent eccentricity measured by optimal coherence tomography | 9 months | — |
| Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT). | 9 month follow-up. | Key secondary |
| All cause death | 12 months | — |
| Death from cardiovascular causes | 12 months | — |
| Target vessel myocardial infarction | 12 months | — |
| Target lesion revascularization | 12 months | — |
| Stent thrombosis | 12 months | — |
| Any myocardial infarction | 12 months | — |
| Stent asymmetry index measured by optimal coherence tomography | 9 months | — |
Countries
Spain
Outcome results
None listed