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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent
The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coroflex® ISAR Drug-eluting stent in first lesion | Active Comparator | Patients with Coroflex® ISAR Drug-eluting stent in the first lesion |
|
| Ultimaster® Drug-eluting stent in first lesion | Active Comparator | Patients with Ultimaster® Drug-eluting stent in first lesion |
|
| Coroflex® ISAR Drug-eluting stent in second lesion | Active Comparator | Patients with with Ultimaster® Drug-eluting stent in first lesion |
|
| Ultimaster® Drug-eluting stent in second lesion | Active Comparator | Patients with Coroflex® ISAR Drug-eluting stent in the first lesion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coroflex® ISAR Drug-eluting stent | Device | Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation. | 3 months | |
| Percentage of covered struts at 3 months OCT after stent implantation. | 3 months | |
| Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation. | 3 months | |
| Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation. | 3 months | |
| Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months | |
| Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
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Inclusion Criteria:
Aged ≥ 18 years
Signature of informed consent
Patients with angina and a clinical indication for coronary revascularisation with a drug-eluting stent
Presence of at least 2 lesions to be revascularised with similar angiographic characteristics
Exclusion Criteria:
Lesions due to restenosis
Lesions in saphenous vein grafts
STE-ACS ( ST elevation- Acute Coronary Syndrome)
Cardiogenic shock
Dual antiplatelet therapy contraindication for> 3 months
Follow-up catheterisation contraindicated
Ineligible for evaluation via optical coherence tomography
Bifurcation lesion requiring a strategy with two stents
Angiographic characteristics that promote stent malposition
Inability to do reliable follow-up, in the investigator's opinion
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| Name | Affiliation | Role |
|---|---|---|
| Bruno GarcÃa del Blanco, MD, PhD | Hospital Universitari Vall d'Hebron (Barcelona) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain | |||
| Hospital ClÃnic de Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17296824 | Background | Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007 Mar 8;356(10):998-1008. doi: 10.1056/NEJMoa067193. Epub 2007 Feb 12. | |
| 19528338 |
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| Ultimaster® Drug-eluting stent | Device | Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion. |
|
| Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months. | 30 days and 3 months and 6 months and 12 months |
| Target lesion revascularization and target vessel revascularization at 30 days, 3 months, 6 months and 12 months OCT after stent implantation . | 30 days and 3 months and 6 months and 12 months |
| Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Healing Score at 1 month and 3 months OCT after stent implantation . | 1 month and 2 months and 3 months |
| Barcelona |
| 08036 |
| Spain |
| Hospital de León | León | 24008 | Spain |
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| Background | Probucol alleviates atherosclerosis and improves high density lipoprotein function. - PubMed - NCBI. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22078494. Accessed October 27, 2015. |
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| 35472561 | Derived | Otaegui Irurueta I, Gonzalez Sucarrats S, Barron Molina JL, Perez de Prado A, Massotti M, Carmona Ramirez MA, Marti G, Bellera N, Serra B, Serra V, Domingo E, Lopez-Benito M, Sabate M, Ferreira Gonzalez I, Garcia Del Blanco B. Can an ultrathin strut stent design and a polymer free, proendothelializing probucol matrix coating improve early strut healing? The FRIENDLY-OCT trial. An intra-patient randomized study with OCT, evaluating early strut coverage of a novel probucol coated polymer-free and ultra-thin strut sirolimus-eluting stent compared to a biodegradable polymer sirolimus-eluting stent. Int J Cardiol. 2022 Aug 1;360:13-20. doi: 10.1016/j.ijcard.2022.04.043. Epub 2022 Apr 25. |
| 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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