- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722799
Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon. (RAMSES)
PROSPECTIVE RANDOMIZED TRIAL Multicentric Study to Evaluate the Treatment and the Efficiency of Paclitaxel-coated Balloon IN.PACT FALCON ® in Small-vessel Coronary Stenosis.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pontevedra
-
Vigo, Pontevedra, Spain, 36312
- Hospital Universitario Alvaro Cunqueiro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Older than 18, informed consent.
- Evidence of CAD with severe de novo lesion in the native coronary arteries ( ≥70% stenosis by visual estimation or >50% by CT scan); affecting
- Vessels between 2,25 and 2,75 mm diameter and
- The length of the coronary stenosis ≤25 mm
- Patient informed consent form signed.
Exclusion Criteria:
- Lesion in coronary left main ,
- Chronic total occlusions,
- Lesions at bifurcation,
- Severe calcified lesions,
- Lesions in aorto-coronary saphenous veins or arterial grafts,
- Acute Myocardial Infarction during 48 hours before the procedure,
- Severe renal dysfunction,
- Hypersensibility, allergy or contraindication of medication: acetylsalicylic acid, clopidogrel, ticlopidine, heparin, paclitaxel,
- Allergy to contrast media,
- Life expectancy less than 1 year,
- 1 year FU not guaranteed,
- Being participating in another study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug elluting Balloon (DEB)
Is a coronary dilating device with Paclitaxel ® drug delivery, for dilatation and provisional spot bare metal stenting (BMS).
|
Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue.
Other Names:
|
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.
|
Percutaneous transluminal coronary angioplasty (PTCA) with stent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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).
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.
|
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).
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.
|
The security will be evaluated at one month, sixth month and one year
|
Secondary Outcome Measures
Outcome Measure |
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.
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.
|
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.
Time Frame: This outcome will be evaluated at first month, 6 month and 1 year.
|
This outcome will be evaluated at first month, 6 month and 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEIX-STENT-001
- RAMSES-DEB (Other Grant/Funding Number: BIOMEDICAL FUNDATION VIGO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Disease
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking University Third HospitalCompletedCoronary Microvascular Dysfunction | Obstructive Coronary Heart DiseaseChina
-
Seung-Jung ParkCardioVascular Research Foundation, KoreaRecruitingCoronary Stenosis | Coronary Artery Bypass Grafting | Coronary Artery Disease Progression | Percutaneous Coronary RevascularizationKorea, Republic of
-
Istanbul UniversityCompletedIschemic Heart Disease | Coronary Microvascular Disease | Microvascular Angina | Coronary Microvascular Dysfunction | Non-Obstructive Coronary Atherosclerosis | Microvascular Coronary Artery DiseaseTurkey
-
Centro de estudios en Cardiologia IntervencionistaCompletedCoronary Heart Disease | Coronary RestenosisArgentina
-
Deutsches Herzzentrum MuenchenCompletedCoronary Heart DiseaseGermany
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Medical University of SilesiaCompletedLeft Main Coronary Artery Disease | Restenosis, Coronary | PTCA Left Main Artery ComplicationsPoland, Italy
Clinical Trials on Drug elluting Balloon (DEB)
-
ZhuHai Cardionovum Medical Device Co., Ltd.R&G Pharma Studies Co.,Ltd.Completed
-
Helsinki University Central HospitalCompletedVascular Access Complication | Restenosis, Vascular Graft | Dialysis Related Complications
-
Helsinki University Central HospitalCompletedPeripheral Artery Occlusive Disease | Peripheral Artery Stenosis | Peripheral Artery RestenosisFinland
-
M.A. Med Alliance S.A.Active, not recruitingPeripheral Artery DiseaseGermany
-
Ralf Degenhardt, PhDB. Braun Melsungen AGCompletedCoronary Heart DiseasesIndia
-
Catholic University of the Sacred HeartUnknown
-
Acotec Scientific Co., LtdCompletedPeripheral Artery DiseaseChina
-
Cathreine BVCatharina Ziekenhuis Eindhoven; St. Antonius Hospital; Medical Centre Leeuwarden and other collaboratorsRecruitingCoronary Artery Disease | Coronary Bifurcation LesionNetherlands
-
MedAlliance, LLCNAMSARecruitingPeripheral Arterial Disease | Chronic Limb-Threatening Ischemia Nos of Native Arteries of ExtremitiesUnited States, Switzerland, New Zealand, Singapore, Hong Kong, Netherlands, France, Germany, Austria, Italy
-
North Karelia Central HospitalTurku University Hospital; Kuopio University Hospital; University of Helsinki; Central...Terminated