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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Pre-dilation with cutting balloon followed by ASES implantation. |
|
| Control group | Active Comparator | Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predilation with cutting balloon. | Device | PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimum stent area post-stenting measured by optimal coherence tomography (OCT) | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT). | Key secondary | 9 month follow-up. |
| Mean stent area measured by optimal coherence tomography | 9 month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Not yet recruiting | Barcelona | Spain |
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Prospective, multicenter, randomized controlled trial
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| Predilation with conventional balloon | Device | PCI will be performed under OCT guidance. Predilation of the lesion will be done with conventional balloon (semi-compliant or non-compliant) |
|
| 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 |
| Stent asymmetry index measured by optimal coherence tomography | 9 months |
| 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 |
| Hospital Universitario y Politécnico La Fe | Recruiting | Valencia | 46026 | Spain |
|
| Hospital General de Valencia | Not yet recruiting | Valencia | Spain |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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