<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/NCT04493112</url>
  </required_header>
  <id_info>
    <org_study_id>Sequent Please NEO</org_study_id>
    <nct_id>NCT04493112</nct_id>
  </id_info>
  <brief_title>SeQuent Please Neo Multicenter Registry</brief_title>
  <official_title>SeQuent Please Neo Multicenter Registry / Registro Multicéntrico Sequent Please NEO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Germans Trias i Pujol Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Germans Trias i Pujol Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The registry evaluates the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo&#xD;
      balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions,&#xD;
      diabetes (diffuse disease) and atrial fibrillation. The objective is to determine the success&#xD;
      of the procedure and the preservation of vascular permeability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The preset registry aim is to evaluate the safety and efficacy of paclitaxel-releasing&#xD;
      SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions,&#xD;
      small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The principal&#xD;
      objective is to determine the success of the procedure and the preservation of vascular&#xD;
      permeability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 5, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.</measure>
    <time_frame>From baseline to 12 months</time_frame>
    <description>Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success of balloon dilation.</measure>
    <time_frame>Baseline</time_frame>
    <description>Success of balloon dilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.</measure>
    <time_frame>From baseline to 12 months</time_frame>
    <description>MACE rate and MACE rate accumulated at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature follow-up indication</measure>
    <time_frame>From baseline to 12 months</time_frame>
    <description>Premature follow-up indication</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Drug Coating Balloon (DCB), Sequent Please</condition>
  <eligibility>
    <study_pop>
      <textblock>
        25 patients approx per site who fulfill inclusion/exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ISR in a coronary artery with a diameter stenosis of at least 70%, a length of the&#xD;
             stented segment of &lt;25 mm, and a vascular diameter of at least 2.5 and up to 3.5 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There is no exclusion criteria except those patients with contraindication for&#xD;
             antiplatelet therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oriol Rodriguez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Germans Trias i Pujol Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Oriol Rodriguez, MD, PhD</last_name>
    <phone>+34 93 497 89 89</phone>
    <email>Oriol.Rodriguez@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oriol Rodriguez, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug coating Balloon (DCB), Sequent Please</keyword>
  <!-- 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/NCT04493112
org study id: Sequent Please NEO
nct id: NCT04493112
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The registry evaluates the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo
      balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions,
      diabetes (diffuse disease) and atrial fibrillation. The objective is to determine the success
      of the procedure and the preservation of vascular permeability.
The preset registry aim is to evaluate the safety and efficacy of paclitaxel-releasing
      SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions,
      small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The principal
      objective is to determine the success of the procedure and the preservation of vascular
      permeability.
observational model: Cohort
time perspective: Prospective
measure: Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
time frame: From baseline to 12 months
description: Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
measure: Success of balloon dilation.
time frame: Baseline
description: Success of balloon dilation.
measure: Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.
time frame: From baseline to 12 months
description: MACE rate and MACE rate accumulated at 12 months.
measure: Premature follow-up indication
time frame: From baseline to 12 months
description: Premature follow-up indication
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Oriol Rodriguez, MD, PhD
role: Principal Investigator
affiliation: Germans Trias i Pujol Hospital
last name: Oriol Rodriguez, MD, PhD
phone: +34 93 497 89 89
email: Oriol.Rodriguez@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor