<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01722799</url>
  </required_header>
  <id_info>
    <org_study_id>MEIX-STENT-001</org_study_id>
    <secondary_id>RAMSES-DEB</secondary_id>
    <nct_id>NCT01722799</nct_id>
  </id_info>
  <brief_title>Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.</brief_title>
  <acronym>RAMSES</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andres Iñiguez Romo, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Meixoeiro</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Significant lesions in small coronary arteries are frequently found (35%-50%) in patients&#xD;
      with coronary artery disease. Independently of the type of coronary angioplasty the&#xD;
      restenosis and the need for repeat revascularization remains the main limitation,&#xD;
      representing a challenging problem even in the DES (drug eluting stent) era. Recently has&#xD;
      been developed drug eluting balloons (DEBs), which have been successfully tested in small&#xD;
      series on in-stent restenosis, but few evidence is available in the context of small vessels&#xD;
      disease.&#xD;
&#xD;
      The current study has been designed to know, in one hand, the clinical efficacy of the Drug&#xD;
      elluting balloon IN.PACT FALCON and, in other hand, the effectiveness, and the&#xD;
      cost-effectiveness incremental analysis of DEBs (IN.PACT FALCON vs. DES ( RESOLUTE INTEGRITY)&#xD;
      in patients with de novo lesions in small vessels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies have reported the efficacy of the local application of paclitaxel ® inhibiting&#xD;
      neointimal proliferation, and thus the limitation of restenosis, which has led to the&#xD;
      conception and development of drug-coated balloon or &quot;Drug Eluting Balloons&quot; (DEB), releasing&#xD;
      the antiproliferative drug at the time of expansion. Initially they were applied in the&#xD;
      treatment of in-stent restenosis. However, DEB may represent a therapeutic alternative in&#xD;
      other contexts where anatomo-clinical uses are not always therapeutic percutaneous coronary&#xD;
      revascularization with stent implantation, as is the case of coronary lesions located in&#xD;
      small vessels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">April 6, 2018</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the clinical efficacy measured by target vessel failure of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES).</measure>
    <time_frame>The efficacy will be evaluated at 1 year.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare the clinical security measured by the incidence MACE of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES).</measure>
    <time_frame>The security will be evaluated at one month, sixth month and one year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>The efficiency will be evaluated at first month, 6 month and 1 year.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the direct cost, indirect costs and total costs of DEBs versus DES in patients with de novo lesions in small vessels.</measure>
    <time_frame>This outcome will be evaluated at first month, 6 month and 1 year.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>Drug elluting Balloon (DEB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Is a coronary dilating device with Paclitaxel ® drug delivery, for dilatation and provisional spot bare metal stenting (BMS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug elluting coronary stent (DES)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Drug elluting Balloon (DEB)</intervention_name>
    <description>Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue.</description>
    <arm_group_label>Drug elluting Balloon (DEB)</arm_group_label>
    <other_name>IN.PACT™ Falcon paclitaxel eluting balloon.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Drug elluting coronary stent (DES)</intervention_name>
    <description>Percutaneous transluminal coronary angioplasty (PTCA) with stent</description>
    <arm_group_label>Drug elluting coronary stent (DES)</arm_group_label>
    <other_name>Resolute integrity™ zotarolimus drug coronary stent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Older than 18, informed consent.&#xD;
&#xD;
          2. Evidence of CAD with severe de novo lesion in the native coronary arteries ( ≥70%&#xD;
             stenosis by visual estimation or &gt;50% by CT scan); affecting&#xD;
&#xD;
          3. Vessels between 2,25 and 2,75 mm diameter and&#xD;
&#xD;
          4. The length of the coronary stenosis ≤25 mm&#xD;
&#xD;
          5. Patient informed consent form signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lesion in coronary left main ,&#xD;
&#xD;
          2. Chronic total occlusions,&#xD;
&#xD;
          3. Lesions at bifurcation,&#xD;
&#xD;
          4. Severe calcified lesions,&#xD;
&#xD;
          5. Lesions in aorto-coronary saphenous veins or arterial grafts,&#xD;
&#xD;
          6. Acute Myocardial Infarction during 48 hours before the procedure,&#xD;
&#xD;
          7. Severe renal dysfunction,&#xD;
&#xD;
          8. Hypersensibility, allergy or contraindication of medication: acetylsalicylic acid,&#xD;
             clopidogrel, ticlopidine, heparin, paclitaxel,&#xD;
&#xD;
          9. Allergy to contrast media,&#xD;
&#xD;
         10. Life expectancy less than 1 year,&#xD;
&#xD;
         11. 1 year FU not guaranteed,&#xD;
&#xD;
         12. Being participating in another study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andres Iñiguez Romo, MD,PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Alvaro Cunqueiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Victor A. Jimenez Diaz, MSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Alvaro Cunqueiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pablo M Juan Salvadores, Pharma; MPH</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario Alvaro Cunqueiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose M. Hernández García., MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Virgen de la Victoria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eduardo Molina Navarro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Virgen de las Nieves</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francisco Bosa Ojeda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Complejo Hospitalario Universitario de Canarias</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Armando Pérez de Prado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario de Leon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fernando Lozano Ruiz-Poveda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario de Ciudad Real</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cristobal A. Urbano Carrillo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clínico Universitario Carlos Haya</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Álvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.cardiologia-vigo.com</url>
    <description>Web Page from Cardiology department.Hospital Meixoeiro.</description>
  </link>
  <results_reference>
    <citation>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.</citation>
    <PMID>20081769</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>20948503</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>19487593</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Meixoeiro</investigator_affiliation>
    <investigator_full_name>Andres Iñiguez Romo, MD, PhD</investigator_full_name>
    <investigator_title>Dr. Andres Iñiguez Romo</investigator_title>
  </responsible_party>
  <keyword>angioplasty</keyword>
  <keyword>Percutaneous Transluminal Coronary Angioplasty</keyword>
  <keyword>Drug elluting Balloon</keyword>
  <keyword>Coronary Balloon</keyword>
  <keyword>Dilatation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01722799
org study id: MEIX-STENT-001
secondary id: RAMSES-DEB
nct id: NCT01722799
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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.
description: 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.
measure: 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
description: 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.
measure: 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.
description: 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.
measure: 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.
arm group label: Drug elluting Balloon (DEB)
arm group type: Experimental
description: Is a coronary dilating device with Paclitaxel ® drug delivery, for dilatation and provisional spot bare metal stenting (BMS).
arm group label: Drug elluting coronary stent (DES)
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: Drug elluting Balloon (DEB)
description: Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue.
arm group label: Drug elluting Balloon (DEB)
other name: IN.PACT™ Falcon paclitaxel eluting balloon.
intervention type: Device
intervention name: Drug elluting coronary stent (DES)
description: Percutaneous transluminal coronary angioplasty (PTCA) with stent
arm group label: Drug elluting coronary stent (DES)
other name: Resolute integrity™ zotarolimus drug coronary stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andres Iñiguez Romo, MD,PHD
role: Principal Investigator
affiliation: Hospital Universitario Alvaro Cunqueiro
last name: Victor A. Jimenez Diaz, MSC
role: Principal Investigator
affiliation: Hospital Universitario Alvaro Cunqueiro
last name: Pablo M Juan Salvadores, Pharma; MPH
role: Study Director
affiliation: Hospital Universitario Alvaro Cunqueiro
last name: Jose M. Hernández García., MD
role: Principal Investigator
affiliation: Hospital Virgen de la Victoria
last name: Eduardo Molina Navarro, MD
role: Principal Investigator
affiliation: Hospital Virgen de las Nieves
last name: Francisco Bosa Ojeda, MD
role: Principal Investigator
affiliation: Complejo Hospitalario Universitario de Canarias
last name: Armando Pérez de Prado, MD
role: Principal Investigator
affiliation: Hospital Universitario de Leon
last name: Fernando Lozano Ruiz-Poveda, MD
role: Principal Investigator
affiliation: Hospital Universitario de Ciudad Real
last name: Cristobal A. Urbano Carrillo
role: Principal Investigator
affiliation: Hospital Clínico Universitario Carlos Haya
facility: 
country: Spain
url: http://www.cardiologia-vigo.com
description: Web Page from Cardiology department.Hospital Meixoeiro.
citation: 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.
PMID: 20081769
citation: 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.
PMID: 20948503
citation: 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.
PMID: 19487593
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital de Meixoeiro
investigator full name: Andres Iñiguez Romo, MD, PhD
investigator title: Dr. Andres Iñiguez Romo
mesh term: Coronary Disease
mesh term: Paclitaxel