Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician.
Post-market, prospective, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A PCI with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. The angiographic study will be analyzed in a core lab (icicorelab) blinded to the procedural outcomes and the patients' follow-up.
As per clinical practice, 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days, a second assessment at 6 months, and one final assessment at 12 months.
Should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a PRECISE-DAPT score ≥ 25- patients will be included in a high-bleeding risk substudy. The antiplatelet therapy regime will be administered according to the local investigator and the treating medical team.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with small native vessel coronary artery disease | - Patients with small native vessel coronary artery disease y/or patients with High Bleeding Risk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention with DCB and DAPT | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of DCB therapy | Incidence of MACE, which is a composite endpoint including cardiac mortality, myocardial infarction, and new revascularization of the target lesion | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | Incidence of Cardiac death | 1 year |
| All-cause mortality | Incidence of All-cause mortality | 1 year |
Not provided
Inclusion Criteria:
Patients with:
syndrome or silent angina with an indication for PCI.
Exclusion Criteria:
Patients with:
Not provided
Not provided
Not provided
drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Mediterranea | Naples | 08122 | Italy | |||
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 74678 | Background | Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available. | |
| 2950322 | Background | Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Target vessel myocardial infarction | Incidence of Target vessel myocardial infarction | 1 year |
| New target lesion revascularization (TLR) | Incidence of New target lesion revascularization (TLR) | 1 year |
| Target vessel failure (TVF) | Incidence of Target vessel failure (TVF) | 1 year |
| Major bleeding | Bleeding defined as BARC (Bleeding Academic Research Consortium) criteria 2,3 or 5 | 1 year |
| Minor bleeding | Anemia, defined as Hb<12g/dL for women and <13g/dL for men | 1 year |
| 1-year MACE indicende (cardiac mortality, myocardial infarction, and new revascularization of the target lesion) in high-bleeding risk patients treated with a short dual antiplatelet treatment (7 days) | safety analysis of short DAP (dual antiplatelet therapy) in terms of thrombotic risk after PCI | 1 year |
| Palermo |
| 90146 |
| Italy |
| Ulslo-H.Santa Cruz | Carnaxide | Portugal |
| ULS Santa Maria | Lisbon | Portugal |
| Hospital General Universitario de Albacete | Albacete | 02008 | Spain |
| Hospital General Universitario Dr. Balmis | Alicante | 03010 | Spain |
| Hospital Universitario de Cruces | Barakaldo | 49803 | Spain |
| University Hospital HM Montepríncipe | Boadilla del Monte | 28660 | Spain |
| Hospital General Universitario de Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Universitario Clinico San Cecilio | Granada | 18016 | Spain |
| Hospital Universitario Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrín | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Universitario de Leon | León | 24071 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Universitario Y Politecnico La Fe | Valencia | 46026 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47003 | Spain |
| 12050336 | Background | Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843. |
| 19528338 | Background | Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jensen LO, Park SJ, Perry R, Racz M, Saia F, Tu JV, Waksman R, Lansky AJ, Mehran R, Stone GW. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009 Jun 30;119(25):3198-206. doi: 10.1161/CIRCULATIONAHA.108.826479. Epub 2009 Jun 15. |
| 25349065 | Background | Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided