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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Hospital de Meixoeiro
Sponsor:
Collaborator:
Hospital de Meixoeiro
Information provided by (Responsible Party):
Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro
ClinicalTrials.gov Identifier:
NCT01722799
First received: September 25, 2012
Last updated: May 10, 2013
Last verified: April 2013
  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 Phase
Coronary Disease
Device: Drug elluting Balloon (DEB)
Device: Drug elluting coronary stent (DES)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 290
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Carlos M. Díaz López, MSC 986811163 ext 211758 carlos.maria.diaz.lopez@sergas.es
Contact: Victor A. Jimenez Díaz, MSC 986811163 ext 211758 victor.alfonso.jimenez.diaz@sergas.es

Locations
Spain
Complejo hospitalario universitario de vigo Recruiting
Vigo, Pontevedra, Spain, 36214
Contact: Carlos M. Díaz-López, MSC    0986811163 ext 211163    carlos.maria.diaz.lopez@sergas.es   
Contact: Victor A. Jimenez-Diaz, MSC    0986811163    victor.alfonso.jimenez.diaz@sergas.es   
Principal Investigator: Andres Iñiguez, Romo         
Sub-Investigator: Victor A. Jimenez Diaz, MSC         
Sub-Investigator: Jose A. Baz Alonso, MD         
Sponsors and Collaborators
Andres Iñiguez Romo, MD, PhD
Hospital de Meixoeiro
Investigators
Study Chair: Andres Iñiguez Romo, PHD Hospital de Meixoeiro
Study Director: Victor A. Jimenez Diaz, MSC Hospital de Meixoeiro
Study Director: Carlos M Diaz Lopez, MSC Hospital de Meixoeiro
Principal Investigator: Carlos Macaya Miguel, PHD Hospital Clínico San Carlos
Principal Investigator: Mariano Valdes Chávarri., PHD Hospital Virgen de la Arrixaca
Principal Investigator: Juan M Durán Hernández, MD Hospital General Yagüe
Principal Investigator: Dr. José F Díaz Hernández., MD. Hospital Juan Ramon Jimenez
Principal Investigator: Armando Bethencourt González, PHD Hospital Son Espases
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 Hospital Virgen de la Candelaria
Principal Investigator: Antoni Serra Peñaranda., MD Hospital San Creu i San Pau
Principal Investigator: Manuel De Sousa Almeida, MD Centro Hospitalar de Lisboa (Hospital Sta Cruz)
Principal Investigator: Rafael Ruiz Salmerón, MD Hospital Virgen de la Macarena
Principal Investigator: Rui Cruz Ferreira., MD. Hospital Lisboa Central (Hospital Sta Marta)
Principal Investigator: Andres Iñiguez Romo, PHD Hospital de Meixoeiro
  More Information

Additional Information:
Publications:
Responsible Party: Andres Iñiguez Romo, MD, PhD, Dr., Hospital de Meixoeiro
ClinicalTrials.gov Identifier: NCT01722799     History of Changes
Other Study ID Numbers: MEIX-STENT-001, RAMSES-DEB
Study First Received: September 25, 2012
Last Updated: May 10, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by 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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014