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| ID | Type | Description | Link |
|---|---|---|---|
| RAMSES-DEB | Other Grant/Funding Number | BIOMEDICAL FUNDATION VIGO |
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Significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. Independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization remains the main limitation, representing a challenging problem even in the DES (drug eluting stent) era. Recently has been developed drug eluting balloons (DEBs), which have been successfully tested in small series on in-stent restenosis, but few evidence is available in the context of small vessels disease.
The current study has been designed to know, in one hand, the clinical efficacy of the Drug elluting balloon IN.PACT FALCON and, in other hand, the effectiveness, and the cost-effectiveness incremental analysis of DEBs (IN.PACT FALCON vs. DES ( RESOLUTE INTEGRITY) in patients with de novo lesions in small vessels.
Recent studies have reported the efficacy of the local application of paclitaxel ® inhibiting neointimal proliferation, and thus the limitation of restenosis, which has led to the conception and development of drug-coated balloon or "Drug Eluting Balloons" (DEB), releasing the antiproliferative drug at the time of expansion. Initially they were applied in the treatment of in-stent restenosis. However, DEB may represent a therapeutic alternative in other contexts where anatomo-clinical uses are not always therapeutic percutaneous coronary revascularization with stent implantation, as is the case of coronary lesions located in small vessels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug elluting Balloon (DEB) | Experimental | Is a coronary dilating device with Paclitaxel ® drug delivery, for dilatation and provisional spot bare metal stenting (BMS). |
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| Drug elluting coronary stent (DES) | Active Comparator | The Resolute Integrity Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.20 mm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug elluting Balloon (DEB) | Device | Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the clinical efficacy measured by target vessel failure of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES). | Target vessel failure (TVF) is define as any revascularization motivated due to myocardial infarction (with or without Q wave) or cardiac death related to the target vessel. | The efficacy will be evaluated at 1 year. |
| Compare the clinical security measured by the incidence MACE of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES). | Rate of major adverse cardiac events (MACE) at 30 days, 6 months and one year. MACE was defined as cardiac death, myocardial infarction (MI) (with or without Q-wave), need for repeat revascularization of the treated vessel (surgical or repeat PCI) or occlusion of the treated lesion. | The security will be evaluated at one month, sixth month and one year |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the efficiency of DEBs versus DES. in terms of cost effectiveness (cost per adverse event-death avoided) and cost-utility ( cost per quality adjusted life year) in patients with de novo lesions in small vessels. | In order to perform a cost-utility analysis, years of quality-adjusted life (QALY) gained will be measured using the quality of life questionnaire EuroQoL five dimensions (EQ-5D) and a visual scale at baseline, one month and 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Iñiguez Romo, MD,PHD | Hospital Universitario Alvaro Cunqueiro | Principal Investigator |
| Victor A. Jimenez Diaz, MSC | Hospital Universitario Alvaro Cunqueiro | Principal Investigator |
| Pablo M Juan Salvadores, Pharma; MPH | Hospital Universitario Alvaro Cunqueiro | Study Director |
| Jose M. Hernández García., MD | Hospital Virgen de la Victoria | Principal Investigator |
| Eduardo Molina Navarro, MD | Hospital Virgen de las Nieves | Principal Investigator |
| Francisco Bosa Ojeda, MD | Complejo Hospitalario Universitario de Canarias | Principal Investigator |
| Armando Pérez de Prado, MD | Hospital Universitario de Leon | Principal Investigator |
| Fernando Lozano Ruiz-Poveda, MD | Hospital Universitario de Ciudad Real | Principal Investigator |
| Cristobal A. Urbano Carrillo | Hospital Clínico Universitario Carlos Haya |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Álvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20081769 | Result | Tepe G, Schmitmeier S, Speck U, Schnorr B, Kelsch B, Scheller B. Advances on drug-coated balloons. J Cardiovasc Surg (Torino). 2010 Feb;51(1):125-43. | |
| 20948503 | Result | Schnorr B, Kelsch B, Cremers B, Clever YP, Speck U, Scheller B. Paclitaxel-coated balloons - Survey of preclinical data. Minerva Cardioangiol. 2010 Oct;58(5):567-82. |
| Label | URL |
|---|---|
| Web Page from Cardiology department.Hospital Meixoeiro. | View source |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Drug elluting coronary stent (DES) | Device | Percutaneous transluminal coronary angioplasty (PTCA) with stent |
|
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| The efficiency will be evaluated at first month, 6 month and 1 year. |
| Compare the direct cost, indirect costs and total costs of DEBs versus DES in patients with de novo lesions in small vessels. | This outcome will be evaluated at first month, 6 month and 1 year. |
| Principal Investigator |
| 19487593 | Result | Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |