Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon. (RAMSES)
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.
|Coronary Disease||Device: Drug elluting Balloon (DEB) Device: Drug elluting coronary stent (DES)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||PROSPECTIVE RANDOMIZED TRIAL Multicentric Study to Evaluate the Treatment and the Efficiency of Paclitaxel-coated Balloon IN.PACT FALCON ® in Small-vessel Coronary Stenosis.|
- Compare the clinical efficacy measured by target vessel failure of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES). [ Time Frame: The efficacy will be evaluated at 1 year. ]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.
- Compare the clinical security measured by the incidence MACE of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES). [ Time Frame: The security will be evaluated at one month, sixth month and one year ]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.
- 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. [ Time Frame: The efficiency will be evaluated at first month, 6 month and 1 year. ]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.
- Compare the direct cost, indirect costs and total costs of DEBs versus DES in patients with de novo lesions in small vessels. [ Time Frame: This outcome will be evaluated at first month, 6 month and 1 year. ]
|Actual Study Start Date:||December 2012|
|Estimated Study Completion Date:||May 2018|
|Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Experimental: Drug elluting Balloon (DEB)
Is a coronary dilating device with Paclitaxel ® drug delivery, for dilatation and provisional spot bare metal stenting (BMS).
Device: Drug elluting Balloon (DEB)
Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue.
Other Name: IN.PACT™ Falcon paclitaxel eluting balloon.
Active Comparator: Drug elluting coronary stent (DES)
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.
Device: Drug elluting coronary stent (DES)
Percutaneous transluminal coronary angioplasty (PTCA) with stent
Other Name: Resolute integrity™ zotarolimus drug coronary stent
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722799
|Hospital Universitario Álvaro Cunqueiro|
|Vigo, Pontevedra, Spain, 36312|
|Principal Investigator:||Andres Iñiguez Romo, MD,PHD||Hospital Universitario Alvaro Cunqueiro|
|Principal Investigator:||Victor A. Jimenez Diaz, MSC||Hospital Universitario Alvaro Cunqueiro|
|Study Director:||Pablo M Juan Salvadores, Pharma; MPH||Hospital Universitario Alvaro Cunqueiro|
|Principal Investigator:||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|