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Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon. (RAMSES)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro
ClinicalTrials.gov Identifier:
NCT01722799
First received: September 25, 2012
Last updated: June 2, 2017
Last verified: June 2017
  Purpose

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.


Condition Intervention
Coronary Disease Device: Drug elluting Balloon (DEB) Device: Drug elluting coronary stent (DES)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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.

Resource links provided by NLM:


Further study details as provided by Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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. ]

Enrollment: 97
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)
Arms Assigned Interventions
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Older than 18, informed consent.
  2. Evidence of CAD with severe de novo lesion in the native coronary arteries ( ≥70% stenosis by visual estimation or >50% by CT scan); affecting
  3. Vessels between 2,25 and 2,75 mm diameter and
  4. The length of the coronary stenosis ≤25 mm
  5. Patient informed consent form signed.

Exclusion Criteria:

  1. Lesion in coronary left main ,
  2. Chronic total occlusions,
  3. Lesions at bifurcation,
  4. Severe calcified lesions,
  5. Lesions in aorto-coronary saphenous veins or arterial grafts,
  6. Acute Myocardial Infarction during 48 hours before the procedure,
  7. Severe renal dysfunction,
  8. Hypersensibility, allergy or contraindication of medication: acetylsalicylic acid, clopidogrel, ticlopidine, heparin, paclitaxel,
  9. Allergy to contrast media,
  10. Life expectancy less than 1 year,
  11. 1 year FU not guaranteed,
  12. Being participating in another study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722799

Locations
Spain
Hospital Universitario Álvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312
Sponsors and Collaborators
Andres Iñiguez Romo, MD, PhD
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
  More Information

Additional Information:
Publications:
Responsible Party: Andres Iñiguez Romo, MD, PhD, Dr. Andres Iñiguez Romo, Hospital de Meixoeiro
ClinicalTrials.gov Identifier: NCT01722799     History of Changes
Other Study ID Numbers: MEIX-STENT-001
RAMSES-DEB ( Other Grant/Funding Number: BIOMEDICAL FUNDATION VIGO )
Study First Received: September 25, 2012
Last Updated: June 2, 2017

Keywords provided by Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro:
angioplasty
Percutaneous Transluminal Coronary Angioplasty
Drug elluting Balloon
Coronary Balloon
Dilatation

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Glucuronyl glucosamine glycan sulfate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017