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Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.
The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device Regulation requirements for post-market clinical follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease (CAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequent Please Neo | Device | Patients in whom treatment with (Sequent Please Neo) has been attempted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events) | Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from MACE in the subgroup of Lesions In-stent Restenosis | Freedom from MACE in the subgroup of Lesions In-stent Restenosis | 12 months |
| Freedom from MACE in the subgroup of Native vessel lesions |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with Sequent Please Neo according to routine hospital practice and following instructions for use.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ORIOL RODRIGUEZ LEOR, MD, PhD | Contact | 0034934651200 | oriolrodriguez@gmail.com | |
| FUNDACION EPIC | Contact | 0034987876135 | iepic@fundacionepic.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Araba | Recruiting | Alava | 01009 | Spain | ||
| Hospital General Universitario de Alicante Dr.Balmis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31204115 | Background | Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13. | |
| 30170854 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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Freedom from MACE in the subgroup of Native vessel lesions
| 12 months |
| Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches | Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches | 12 months |
| Procedural success | Procedural success ( Residual stenosis <30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure) | Immediately after PCI (Percutaneous Coronary Intervention) |
| Recruiting |
| Alicante |
| 03010 |
| Spain |
| Hospital Universitario de Badajoz | Recruiting | Badajoz | 06080 | Spain |
| Hospital Universitari Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hospital Universitario de Cruces | Recruiting | Barakaldo | 48903 | Spain |
| Hospital de La Santa Creu Y Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario Puerta Del Mar | Recruiting | Cadiz | 11009 | Spain |
| Hospital General Universitari de Castelló | Recruiting | Castelló | 12004 | Spain |
| Hospital Universitario San Pedro de Alcantara | Recruiting | Cáceres | 10003 | Spain |
| Hospital Universitario de Ciudad Real | Recruiting | Ciudad Real | 13005 | Spain |
| Hospital General Universitario de Elche | Recruiting | Elche | 03203 | Spain |
| Hospital Universitario de Cabueñes | Recruiting | Gijón | 33394 | Spain |
| Hospital Universitari Dr. Josep Trueta | Recruiting | Girona | 17007 | Spain |
| Hospital Universitario Juan Ramon Jimenez | Recruiting | Huelva | 21005 | Spain |
| Hospital Universitario de Jaen | Recruiting | Jaén | 23007 | Spain |
| Hospital Universitario de Leon | Recruiting | León | 240801 | Spain |
| Hospital Universitario Lucus Agusti | Recruiting | Lugo | 27003 | Spain |
| Hospital Universitario de La Princesa | Recruiting | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Regional Universitario de Malaga | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de La Victoria | Recruiting | Málaga | 29010 | Spain |
| Hospital de Mérida | Recruiting | Mérida | 06800 | Spain |
| Hospital Universitario Puerto Real | Recruiting | Puerto Real | 11510 | Spain |
| Hospital Clinico Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital General Universitario de Toledo | Recruiting | Toledo | 45007 | 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. |
| 26139054 | Background | Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Benedicto A, Masotti M, Zueco J, Iniguez A, Velazquez M, Moreno R, Mainar V, Dominguez A, Pomar F, Melgares R, Rivero F, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS IV Study Investigators (under auspices of Interventional Cardiology Working Group of Spanish Society of Cardiology). A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial. J Am Coll Cardiol. 2015 Jul 7;66(1):23-33. doi: 10.1016/j.jacc.2015.04.063. |
| 17101615 | Background | Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13. |
| 20052480 | Background | Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010 Mar;99(3):165-74. doi: 10.1007/s00392-009-0101-6. Epub 2010 Jan 6. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |