<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/NCT04403815</url>
  </required_header>
  <id_info>
    <org_study_id>1136</org_study_id>
    <nct_id>NCT04403815</nct_id>
  </id_info>
  <brief_title>Radiation Exposure During Coronary Procedures According to Vascular Access</brief_title>
  <official_title>Determinants of Operator Radiation Exposure During Percutaneous Coronary Procedures According to Vascular Access: the RADIANT II Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda ULSS 3 Serenissima</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda ULSS 3 Serenissima</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>
      Trial's objective is to evaluate:&#xD;
&#xD;
      i. if there's any difference between the operator radiation exposure during diagnostic&#xD;
      coronary angiography and/or percutaneous coronary intervention (PCI) performed through&#xD;
      right-side artery accesses (wrist transradial access and distal transradial access) versus&#xD;
      left distal radial artery access ii. the relationship between operator radiation exposure and&#xD;
      other clinical and procedural characteristics, to assess independent predictors of operator&#xD;
      radiation exposure. Design of the study: prospective multicenter observational cohort&#xD;
      registry (OCR).&#xD;
&#xD;
      The purpose of this OCR is to assess the radiation exposure of interventional cardiologist&#xD;
      during a diagnostic coronary angiography and/or PCI according to vascular access used (see&#xD;
      above). Coronary angiography and PCI will be performed according to usual practice&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient population:&#xD;
&#xD;
      During 6 months, at least 1000 consecutive patients (age &gt; 18 years) referred for diagnostic&#xD;
      coronary angiography in up to 10 centers in Italy involving a minimum of 4 operators will be&#xD;
      enrolled. To be qualified as expert, operators should have performed at least 250 transradial&#xD;
      procedure/year in the previous 3 years and have performed at least 20 right and left distal&#xD;
      radial procedures.&#xD;
&#xD;
      Demographic and medical history data of patients including age, sex, history of diabetes&#xD;
      mellitus, hypertension, height and weight will be collected. Height and weight of operators&#xD;
      will be also recorded. Type of angiographic system will be recorded. Procedural data as&#xD;
      contrast medium amount, subclavian tortuosity, numbers of diagnostic and guiding catheters&#xD;
      and numbers of cine-angiographic acquisitions (frames) will be also recorded.&#xD;
&#xD;
      Subclavian tortuosity will be classified as:&#xD;
&#xD;
        -  Grade 1: tortuosity or calcification of the subclavian artery that can be crossed by a&#xD;
           standard 0.035&quot; nonhydrophilic wire facilitated with deep inspiration&#xD;
&#xD;
        -  Grade 2: tortuosity or calcification of the subclavian artery that can be crossed with a&#xD;
           0.0035&quot; hydrophilic wire and a standard diagnostic catheter&#xD;
&#xD;
        -  Grade 3: tortuosity or calcification of the subclavian artery or congenital anomalies&#xD;
           that require a 0.035&quot; stiff wire and a standard catheter&#xD;
&#xD;
        -  Grade 4: severe tortuosity and/or calcification of the subclavian artery or congenital&#xD;
           anomalies preventing the catheter or guide to reach the aortic valve plane or engage the&#xD;
           coronary ostia with a stiff wire Subclavian tortuosity &gt; grade 2 will be considered as&#xD;
           significative. Type of catheters and the number of views for angiography and PCI will be&#xD;
           left to the discretion of the operator. Lead shields placed under the catheterization&#xD;
           table, as well as ceiling mounted lead shields, will be used in every procedure.&#xD;
           Procedural success is defined as completion of the procedure through the intended&#xD;
           arterial access. Crossover, if needed, is permitted to femoral access or to&#xD;
           contralateral arm or approach.&#xD;
&#xD;
      Arterial access protocol:&#xD;
&#xD;
      Right radial access: radial artery access will be obtained with a 20-gauge Teflonsheated&#xD;
      needle using the Seldinger or the counter puncture technique. An introducer sheath is&#xD;
      inserted in the radial artery according to local practice. An intra-arterial vasodilator&#xD;
      cocktail will be administered consisting of ntroglycerin 200 mcg and verapamil 5 mg after&#xD;
      sheath insertion. 5000 IU of unfractioned heparin will be administered intravenously after&#xD;
      sheath insertion, and adequately adjusted in case of interventions. The introducer sheath&#xD;
      will be removed at the end of the procedure, and a mechanical or inflatable pressure band&#xD;
      will be applied to the access site to achieve hemostasis.&#xD;
&#xD;
      Distal radial accesses: following distal radial artery palpation, 1 of the 2 possible&#xD;
      puncture sites (anatomic snuffbox or in the first intermetacarpal space) is chosen. In case&#xD;
      of left-side access, the left hand is bent toward the left groin with support below the left&#xD;
      elbow to ensure patient's comfort. The operator is positioned at the right side of the&#xD;
      patient. To favor a shift of the distal radial artery to the surface of the fossa, the&#xD;
      patient is asked to grasp his or her thumb under the other 4 fingers or to hold a roll of&#xD;
      gauze, a 20 ml syringe, or the handle of a dedicated system. After disinfection and local&#xD;
      anesthesia, the artery is punctured according to operator preference and/or experience using&#xD;
      a micropuncture needle or a cannula-over-needle. An introducer sheath (preferably a slender&#xD;
      introducer sheath) is inserted in the radial artery according to local practice. An&#xD;
      intra-arterial vasodilator cocktail will be administered consisting of nitroglycerin 200 mcg&#xD;
      and verapamil 5 mg after sheath insertion. 5000 IU of unfractioned heparin will be&#xD;
      administered intravenously after sheath insertion, and adequately adjusted in case of&#xD;
      interventions.&#xD;
&#xD;
      Coronary catheterization:&#xD;
&#xD;
      Angiographic systems were set according to the standard of the operators, and the field of&#xD;
      view or fluoroscopic and cine-acquisition speed will be recorded for each procedure. The&#xD;
      diagnostic procedures will be performed using a standard sequence of 3 projections for the&#xD;
      right coronary artery and maximum 6 projections for the left coronary artery. Differently,&#xD;
      the percutaneous coronary interventions will be performed according to the lesion and to the&#xD;
      operator preference.&#xD;
&#xD;
      Vascular access as well as the sheath selection, catheter curve used, and the use of&#xD;
      adjunctive tools will be at the discretion of the operator involved in the procedure.&#xD;
&#xD;
      In all procedures, standard operator radioprotection will be ensured using a lead apron, a&#xD;
      thyroid lead collar, lower body x-ray curtain fixed on the angiographic table, an upper&#xD;
      mobile leaded glass suspended from the ceiling, and leaded glasses. The use of adjunctive&#xD;
      protective drapes to reduce operator radiation exposition ws left to the operator's&#xD;
      discretion&#xD;
&#xD;
      Radiation measurement:&#xD;
&#xD;
      Radiation measures collected are fluoroscopy time (expressed in minutes), the AK (expressed&#xD;
      in mGy) and the DAP (expressed in Gy*cm2). The number of acquired cineangiograms will be&#xD;
      recorded. Fluoroscopy and cineangiography will be performed at 7.5 or 15 frames/s according&#xD;
      to operators' preferences.&#xD;
&#xD;
      Operator radiation exposure is measured for each participating operator using 1 dedicated&#xD;
      electronic dosimeter (PM1610B; Polimaster, Vienna, Austria) to be worn at mid-thorax level,&#xD;
      in the breast pocket outside the lead apron, and expressed in µSy. The radiation and operator&#xD;
      measures will be recorded at the beginning and the end of each procedure. For those patients&#xD;
      who undergo a PCI after the diagnostic procedure, the measures of fluoroscopy time, DAP, and&#xD;
      dose of the wearable dosimeters will be reset after the end of the diagnostic procedure and&#xD;
      restart at the beginning of the PCI. To take into account possible differences in patient&#xD;
      radiation dose affecting the operator exposure, the DAP-normalized operator dose will be also&#xD;
      calculated.&#xD;
&#xD;
      The equivalent dose at the thorax will be also converted in operator effective dose dividing&#xD;
      it by a factor of 33 according to apron thickness, 0.5 lead equivalent with a tube voltage&#xD;
      under the table. Patient effective dose will be calculated using a conversion factor of 0.20&#xD;
      mSv/Gy*cm2.&#xD;
&#xD;
      Statistical Hypothesis and analysis:&#xD;
&#xD;
      the null hypothesis is that ld-TRA exposure to radiation is the same as right-side TRA&#xD;
      (access site at the wrist and at the anatomical snuffbox of the right hand). In the previous&#xD;
      RADIANT study right-side TRA was associated with a mean operator exposition of 13 µSy (SD +10&#xD;
      µSy); hence, to detect non-inferiority between the two groups (risk of type I error 5%, risk&#xD;
      of type II error 80%, non-inferiority limit 3 µSy) at least 138 per group are needed. The&#xD;
      alternative hypothesis is that ld-TRA exposure is reduced compared to rightside TRA. The&#xD;
      amount of this reduction is to be determined. An arbitrary period of 6 months should be&#xD;
      sufficient to record the radiological exposition in at least 1000 procedures. Taking into&#xD;
      account possible crossover between groups, a minimum proportion of 20% of procedures through&#xD;
      distal left radial artery PCIs was mandated to guarantee adequate numerosity of the group.&#xD;
      Kolmogorov-Smirnov analysis will be performed to evaluate the distribution of each variable&#xD;
      analyzed. Categorical variables will be analyzed using chi-square test, and continuous&#xD;
      variables will be analyzed using analysis of variance for normally distributed variables and&#xD;
      Kruskal-Wallis test for variables with distribution that were not normal. If needed,&#xD;
      log-transformation of non-normal variables will be performed. Hierarchical linear regression&#xD;
      will be used to identify independent predictors of radiation exposure, entering control&#xD;
      variables found to be significantly associated with radiation exposure on univariate&#xD;
      analysis. Propensity score matching will be performed to minimize the risks of imbalances due&#xD;
      to variation in the complexity of the diagnostic or therapeutic procedures within each&#xD;
      operators. Prespecified analysis of subgroups (diagnostic coronary angiography vs PCI, expert&#xD;
      operators vs fellows, use of adjunctive drapes, physical characteristics of operators) could&#xD;
      be planned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>mean operator radiation dose</measure>
    <time_frame>1 year</time_frame>
    <description>mean operator radiation dose at the torax (expressed in µSy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient radiation exposure</measure>
    <time_frame>from beginning to end of coronary procedure</time_frame>
    <description>Patient effective dose: operator effective dose divided by a conversion factor of 0.20 mSv/Gy*cm2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean fluoroscopy time</measure>
    <time_frame>1 year</time_frame>
    <description>mean fluoroscopy time (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean DAP-normalized operator dose</measure>
    <time_frame>1 year</time_frame>
    <description>operator radiation dose divided by DAP values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean operator effective dose</measure>
    <time_frame>1 year</time_frame>
    <description>Operator effective dose: operator radiation exposure divided by 0.33</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Radiation Exposure</condition>
  <arm_group>
    <arm_group_label>right radial access</arm_group_label>
    <description>diagnostic coronary angiography and/or PCI performed through right wrist and distal (&quot;snuffbox&quot;) radial access</description>
  </arm_group>
  <arm_group>
    <arm_group_label>left distal radial access</arm_group_label>
    <description>diagnostic coronary angiography and/or PCI performed through left distal (&quot;snuffbox&quot;) radial access</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>vascular access for coronary procedures</intervention_name>
    <description>comparison of x-rays exposition of interventional cardiologist according to vascular access used</description>
    <arm_group_label>left distal radial access</arm_group_label>
    <arm_group_label>right radial access</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all-comers undergoing to diagnostic coronary angiography and/or PCI through transradial&#xD;
        access&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients admitted for coronary diagnostic angiography in the setting of valvular&#xD;
             disease, stable angina, suspected coronary artery disease, acute coronary syndrome&#xD;
             with or without ST segment elevation myocardial infarction who underwent diagnostic&#xD;
             coronary angiography through right radial, right distal radial and left distal radial&#xD;
             access.&#xD;
&#xD;
          -  patients admitted for ad-Hoc PCI through any radial access&#xD;
&#xD;
          -  patients age &gt; 18 years-old&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hemodynamic instability&#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_contact>
    <last_name>Andrea pacchioni, MD</last_name>
    <phone>00390415794241</phone>
    <phone_ext>4241</phone_ext>
    <email>andreapacchioni@gmail.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04403815
org study id: 1136
nct id: NCT04403815
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Trial's objective is to evaluate:

      i. if there's any difference between the operator radiation exposure during diagnostic
      coronary angiography and/or percutaneous coronary intervention (PCI) performed through
      right-side artery accesses (wrist transradial access and distal transradial access) versus
      left distal radial artery access ii. the relationship between operator radiation exposure and
      other clinical and procedural characteristics, to assess independent predictors of operator
      radiation exposure. Design of the study: prospective multicenter observational cohort
      registry (OCR).

      The purpose of this OCR is to assess the radiation exposure of interventional cardiologist
      during a diagnostic coronary angiography and/or PCI according to vascular access used (see
      above). Coronary angiography and PCI will be performed according to usual practice
Patient population:

      During 6 months, at least 1000 consecutive patients (age > 18 years) referred for diagnostic
      coronary angiography in up to 10 centers in Italy involving a minimum of 4 operators will be
      enrolled. To be qualified as expert, operators should have performed at least 250 transradial
      procedure/year in the previous 3 years and have performed at least 20 right and left distal
      radial procedures.

      Demographic and medical history data of patients including age, sex, history of diabetes
      mellitus, hypertension, height and weight will be collected. Height and weight of operators
      will be also recorded. Type of angiographic system will be recorded. Procedural data as
      contrast medium amount, subclavian tortuosity, numbers of diagnostic and guiding catheters
      and numbers of cine-angiographic acquisitions (frames) will be also recorded.

      Subclavian tortuosity will be classified as:

        -  Grade 1: tortuosity or calcification of the subclavian artery that can be crossed by a
           standard 0.035" nonhydrophilic wire facilitated with deep inspiration

        -  Grade 2: tortuosity or calcification of the subclavian artery that can be crossed with a
           0.0035" hydrophilic wire and a standard diagnostic catheter

        -  Grade 3: tortuosity or calcification of the subclavian artery or congenital anomalies
           that require a 0.035" stiff wire and a standard catheter

        -  Grade 4: severe tortuosity and/or calcification of the subclavian artery or congenital
           anomalies preventing the catheter or guide to reach the aortic valve plane or engage the
           coronary ostia with a stiff wire Subclavian tortuosity > grade 2 will be considered as
           significative. Type of catheters and the number of views for angiography and PCI will be
           left to the discretion of the operator. Lead shields placed under the catheterization
           table, as well as ceiling mounted lead shields, will be used in every procedure.
           Procedural success is defined as completion of the procedure through the intended
           arterial access. Crossover, if needed, is permitted to femoral access or to
           contralateral arm or approach.

      Arterial access protocol:

      Right radial access: radial artery access will be obtained with a 20-gauge Teflonsheated
      needle using the Seldinger or the counter puncture technique. An introducer sheath is
      inserted in the radial artery according to local practice. An intra-arterial vasodilator
      cocktail will be administered consisting of ntroglycerin 200 mcg and verapamil 5 mg after
      sheath insertion. 5000 IU of unfractioned heparin will be administered intravenously after
      sheath insertion, and adequately adjusted in case of interventions. The introducer sheath
      will be removed at the end of the procedure, and a mechanical or inflatable pressure band
      will be applied to the access site to achieve hemostasis.

      Distal radial accesses: following distal radial artery palpation, 1 of the 2 possible
      puncture sites (anatomic snuffbox or in the first intermetacarpal space) is chosen. In case
      of left-side access, the left hand is bent toward the left groin with support below the left
      elbow to ensure patient's comfort. The operator is positioned at the right side of the
      patient. To favor a shift of the distal radial artery to the surface of the fossa, the
      patient is asked to grasp his or her thumb under the other 4 fingers or to hold a roll of
      gauze, a 20 ml syringe, or the handle of a dedicated system. After disinfection and local
      anesthesia, the artery is punctured according to operator preference and/or experience using
      a micropuncture needle or a cannula-over-needle. An introducer sheath (preferably a slender
      introducer sheath) is inserted in the radial artery according to local practice. An
      intra-arterial vasodilator cocktail will be administered consisting of nitroglycerin 200 mcg
      and verapamil 5 mg after sheath insertion. 5000 IU of unfractioned heparin will be
      administered intravenously after sheath insertion, and adequately adjusted in case of
      interventions.

      Coronary catheterization:

      Angiographic systems were set according to the standard of the operators, and the field of
      view or fluoroscopic and cine-acquisition speed will be recorded for each procedure. The
      diagnostic procedures will be performed using a standard sequence of 3 projections for the
      right coronary artery and maximum 6 projections for the left coronary artery. Differently,
      the percutaneous coronary interventions will be performed according to the lesion and to the
      operator preference.

      Vascular access as well as the sheath selection, catheter curve used, and the use of
      adjunctive tools will be at the discretion of the operator involved in the procedure.

      In all procedures, standard operator radioprotection will be ensured using a lead apron, a
      thyroid lead collar, lower body x-ray curtain fixed on the angiographic table, an upper
      mobile leaded glass suspended from the ceiling, and leaded glasses. The use of adjunctive
      protective drapes to reduce operator radiation exposition ws left to the operator's
      discretion

      Radiation measurement:

      Radiation measures collected are fluoroscopy time (expressed in minutes), the AK (expressed
      in mGy) and the DAP (expressed in Gy*cm2). The number of acquired cineangiograms will be
      recorded. Fluoroscopy and cineangiography will be performed at 7.5 or 15 frames/s according
      to operators' preferences.

      Operator radiation exposure is measured for each participating operator using 1 dedicated
      electronic dosimeter (PM1610B; Polimaster, Vienna, Austria) to be worn at mid-thorax level,
      in the breast pocket outside the lead apron, and expressed in µSy. The radiation and operator
      measures will be recorded at the beginning and the end of each procedure. For those patients
      who undergo a PCI after the diagnostic procedure, the measures of fluoroscopy time, DAP, and
      dose of the wearable dosimeters will be reset after the end of the diagnostic procedure and
      restart at the beginning of the PCI. To take into account possible differences in patient
      radiation dose affecting the operator exposure, the DAP-normalized operator dose will be also
      calculated.

      The equivalent dose at the thorax will be also converted in operator effective dose dividing
      it by a factor of 33 according to apron thickness, 0.5 lead equivalent with a tube voltage
      under the table. Patient effective dose will be calculated using a conversion factor of 0.20
      mSv/Gy*cm2.

      Statistical Hypothesis and analysis:

      the null hypothesis is that ld-TRA exposure to radiation is the same as right-side TRA
      (access site at the wrist and at the anatomical snuffbox of the right hand). In the previous
      RADIANT study right-side TRA was associated with a mean operator exposition of 13 µSy (SD +10
      µSy); hence, to detect non-inferiority between the two groups (risk of type I error 5%, risk
      of type II error 80%, non-inferiority limit 3 µSy) at least 138 per group are needed. The
      alternative hypothesis is that ld-TRA exposure is reduced compared to rightside TRA. The
      amount of this reduction is to be determined. An arbitrary period of 6 months should be
      sufficient to record the radiological exposition in at least 1000 procedures. Taking into
      account possible crossover between groups, a minimum proportion of 20% of procedures through
      distal left radial artery PCIs was mandated to guarantee adequate numerosity of the group.
      Kolmogorov-Smirnov analysis will be performed to evaluate the distribution of each variable
      analyzed. Categorical variables will be analyzed using chi-square test, and continuous
      variables will be analyzed using analysis of variance for normally distributed variables and
      Kruskal-Wallis test for variables with distribution that were not normal. If needed,
      log-transformation of non-normal variables will be performed. Hierarchical linear regression
      will be used to identify independent predictors of radiation exposure, entering control
      variables found to be significantly associated with radiation exposure on univariate
      analysis. Propensity score matching will be performed to minimize the risks of imbalances due
      to variation in the complexity of the diagnostic or therapeutic procedures within each
      operators. Prespecified analysis of subgroups (diagnostic coronary angiography vs PCI, expert
      operators vs fellows, use of adjunctive drapes, physical characteristics of operators) could
      be planned.
observational model: Cohort
time perspective: Prospective
measure: mean operator radiation dose
time frame: 1 year
description: mean operator radiation dose at the torax (expressed in µSy)
measure: patient radiation exposure
time frame: from beginning to end of coronary procedure
description: Patient effective dose: operator effective dose divided by a conversion factor of 0.20 mSv/Gy*cm2
measure: mean fluoroscopy time
time frame: 1 year
description: mean fluoroscopy time (minutes)
measure: mean DAP-normalized operator dose
time frame: 1 year
description: operator radiation dose divided by DAP values
measure: mean operator effective dose
time frame: 1 year
description: Operator effective dose: operator radiation exposure divided by 0.33
arm group label: right radial access
description: diagnostic coronary angiography and/or PCI performed through right wrist and distal ("snuffbox") radial access
arm group label: left distal radial access
description: diagnostic coronary angiography and/or PCI performed through left distal ("snuffbox") radial access
intervention type: Procedure
intervention name: vascular access for coronary procedures
description: comparison of x-rays exposition of interventional cardiologist according to vascular access used
arm group label: left distal radial access
arm group label: right radial access
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea pacchioni, MD
phone: 00390415794241
phone ext: 4241
email: andreapacchioni@gmail.com
responsible party type: Sponsor
sharing ipd: No