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Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR (in-stent restenosis) in all settings, in order to evaluate its effectiveness and safety.
The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.
Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR in all settings, in order to evaluate its effectiveness and safety.
The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease (CAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SELUTION SLRTM sirolimus coated balloon | Device | Patients in whom treatment with SELUTION SLRTM sirolimus coated balloon has been attempted |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE (Major Adverse Cardiovascular Events) | Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization) | 12 months |
| TLR | Number of Target Lesion Revascularizations | 12 months |
| DoCE (Device-oriented Composite Endpoint) | Incidence of DoCE, defined as Cardiovascular death, device failure-related MI (Myocardial Infarction) or device failure-related ischaemia) | 12 months |
| PoCE (Patient-oriented Composite Endpoint) | Incidence of PoCE defined as all cause death, any stroke, any MI or any revascularization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| TLR in ISR | Number of Target Lesion Revascularizations in patients with ISR (in-stent restenosis) | 12 months |
| TLR in primary lesions in native vessel | Number of Target Lesion Revascularizations in primary lesions in native vessel |
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Inclusion Criteria:
Exclusion Criteria:
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All patients treated with the Selution SLRTM device
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ORIOL RODRIGUEZ LEOR, MD, PhD | Contact | 0034934978989 | oriolrodriguez@gmail.com | |
| FUNDACION EPIC | Contact | 0034987876135 | iepic@fundacionepic.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Pontevedra | Recruiting | Vilagarcía de Arousa | Pontevedra | 36619 | Spain | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22386286 | Background | Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012 Apr 10;59(15):1377-82. doi: 10.1016/j.jacc.2012.01.015. Epub 2012 Feb 29. | |
| 30170854 |
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| 12 months |
| TLR in bifurcation side branch lesions | Number of Target Lesion Revascularizations in bifurcation side branch lesions | 12 months |
| MACE (Major Adverse Cardiovascular Events) in ISR | Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization) in ISR | 12 months |
| MACE (Major Adverse Cardiovascular Events) in primary lesions in native vessel | Incidence of MACE defined as death, non fatal myocardial infarction, or need for TLR (Target Target Lesion Revascularization) in primary lesions in native vessel | 12 months |
| MACE (Major Adverse Cardiovascular Events) in bifurcation side branch lesions | Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization) in primary lesions in bifurcation side branch lesions | 12 months |
| Procedure success | Device success defined as residual stenosis <30% by visual assessment and or online QCA (Quantitative Coronary Analysis) < 40%, absence of dissection and TIMI 3 flow | 1 day |
| Death | Incidence of Death defined as all-cause, cardiac, device related, procedure related | 12 months |
| Non fatal Myocardial Infarction | Incidence of Non fatal Myocardial Infarction | 12 months |
| Hospital Universitari Germans Trias i Pujol |
| Recruiting |
| Badalona |
| 08916 |
| Spain |
| Hospital del Mar | Recruiting | Barcelona | 08003 | Spain |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | 38320 | Spain |
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hospital Clinico Universitario de Santiago | Recruiting | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital Universitari MútuaTerrassa | Recruiting | Terrassa | 08221 | Spain |
| Hospital Universitario de Torrevieja | Recruiting | Torrevieja | 03186 | Spain |
| Background |
| Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28. |
| 36192319 | Background | Costa RA, Mandal SC, Hazra PK, Chopda M, Chandra P, Damiani LP, Abizaid A, Hiremath S. Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions. Cardiovasc Revasc Med. 2022 Dec;45:18-25. doi: 10.1016/j.carrev.2022.08.037. Epub 2022 Sep 5. |
| 36385601 | Background | Madanchi M, Cioffi GM, Attinger-Toller A, Seiler T, Somm S, Koch T, Tersalvi G, Wolfrum M, Moccetti F, Toggweiler S, Kobza R, Levine MB, Garcia-Garcia HM, Bossard M, Cuculi F. Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon. Cardiol J. 2022;29(6):906-916. doi: 10.5603/CJ.a2022.0106. Epub 2022 Nov 17. |
| 36642225 | Background | Spaulding C, Krackhardt F, Bogaerts K, Urban P, Meis S, Morice MC, Eccleshall S. Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial. Am Heart J. 2023 Apr;258:77-84. doi: 10.1016/j.ahj.2023.01.007. Epub 2023 Jan 13. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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