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

August 1, 2018 updated by: Andres Iñiguez Romo, MD, PhD

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

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Hospital Universitario Alvaro Cunqueiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 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.
Percutaneous transluminal coronary angioplasty (PTCA) with stent
Other Names:
  • Resolute integrity™ zotarolimus drug coronary stent

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

April 6, 2018

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

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.

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