<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/NCT03300167</url>
  </required_header>
  <id_info>
    <org_study_id>STH19267</org_study_id>
    <nct_id>NCT03300167</nct_id>
  </id_info>
  <brief_title>Study of the Vascular Response to Percutaneous Coronary Intervention in Patients With Non-ST-elevation Acute Coronary Syndromes Using Intravascular Blood Sampling</brief_title>
  <acronym>IN HEART</acronym>
  <official_title>Study of the Vascular Response to Percutaneous Coronary Intervention in Patients With Non-ST-elevation Acute Coronary Syndromes Using Intravascular Blood Sampling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This interventional study is using the PlaqueTec LBS will enrol participants already&#xD;
      undergoing coronary angiography as a component of their standard care for NSTE-ACS. The study&#xD;
      will involve no change to medication or overall treatment strategy, but will involve an&#xD;
      additional procedure: use of a novel CE-marked coronary artery catheter to obtain&#xD;
      spatially-separated intravascular samples for laboratory measurement. As a safety objective&#xD;
      and as a component of the required post-marketing surveillance, OCT will be performed before&#xD;
      and after deployment of the LBS, and patients will be followed up for a significant period of&#xD;
      time by the investigator's post-procedure.&#xD;
&#xD;
      Individual participants will not gain directly from taking part in the study, other than&#xD;
      having access to more prolonged follow up than is standard. However, new insights will be&#xD;
      gained into the microenvironment surrounding a ruptured plaque in NSTE-ACS, which has the&#xD;
      potential to benefit patients with CAD in the future through greater understanding of the&#xD;
      effects of current therapy, development of new treatment strategies and methods of assessing&#xD;
      the efficacy of those treatment strategies.&#xD;
&#xD;
      Use of the LBS and the associated OCT examinations will require additional angiographic&#xD;
      screening and therefore lead to greater exposure to radiation and higher contrast load. This&#xD;
      will be closely monitored as per Trust policies in line with IRMER and local radiological&#xD;
      guidelines. Patients at particular risk of developing complications from increased exposure&#xD;
      to radiation and contrast (eg. those who are pregnant and those with abnormal baseline renal&#xD;
      function) will not be included in order to minimise adverse effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical protocol will be subject to peer review according to standard local procedures,&#xD;
      including independent scientific review by the Scientific Advisory Board of the Clinical&#xD;
      Research Facility, Sheffield Teaching Hospitals NHS Foundation Trust; the Clinical Research&#xD;
      Office, Sheffield Teaching Hospitals NHS Foundation Trust; and the Research Ethics Committee.&#xD;
      The study will be a single-centre study including use of a CE-marked medical device to obtain&#xD;
      samples, conducted at Cardiology and Cardiothoracic Surgery Directorate, Northern General&#xD;
      Hospital, Sheffield Teaching Hospitals NHS Foundation Trust.&#xD;
&#xD;
      Patients with a diagnosis of NSTE-ACS, receiving DAPT with a combination of aspirin and&#xD;
      ticagrelor or prasugrel, and listed either for coronary angiography with the intention of&#xD;
      proceeding to PCI or for PCI following coronary angiography at a referring hospital, will be&#xD;
      approached and their informed consent sought for this study. 18 patients found to have&#xD;
      culprit significant proximal epicardial coronary artery stenosis suitable for PCI, meeting&#xD;
      all the inclusion and exclusion criteria, will proceed to have platelet function testing and&#xD;
      LBS measurements. Blood will be taken from the arterial sheath or guide catheter and baseline&#xD;
      platelet function testing will be performed (VerifyNow P2Y12 assay; light transmittance&#xD;
      aggregometry with ADP and arachidonic acid as agonists; and serum thromboxane B2 assay).&#xD;
      Balloon predilatation prior to stent deployment will be a mandatory requirement for the&#xD;
      study. Following balloon predilatation, the LBS will be deployed across the treated lesion&#xD;
      and blood sampling will be performed proximal and distal to the lesion at approximately 5&#xD;
      minutes after predilatation. The following assays will be performed on the sampled blood:&#xD;
&#xD;
        1. Plasma levels of soluble markers of thrombosis and inflammation including prothrombin&#xD;
           fragments 1 and 2, fibrinopeptide A, soluble P-selectin and thromboxane B2.&#xD;
&#xD;
        2. Platelet surface P-selectin expression&#xD;
&#xD;
        3. Leukocyte surface CD11b expression Blood taken prior to PCI will also be sent to the&#xD;
           local laboratory for measurement of the cardiac-specific marker high-sensitivity&#xD;
           troponin T and a further venous blood sample will be collected at 6 hours after PCI to&#xD;
           measure any rise in troponin in order to correlate this with thrombin generation. A rise&#xD;
           of 5 times the upper limit of normal of troponin following PCI in the context of chest&#xD;
           pain or diagnostic ECG changes will be used to define peri-procedural myocardial&#xD;
           infarction per the Universal Definition of Myocardial Infarction (Thygesen, Alpert et&#xD;
           al. 2012).&#xD;
&#xD;
      OCT of the culprit lesion, as well as the coronary artery proximal and distal to this, will&#xD;
      be performed before and after the deployment of the LBS to assess any topographical changes&#xD;
      to the vessel wall caused by the LBS and provide information on target lesion morphology.&#xD;
&#xD;
      Clinical outcomes will be reviewed and AEs (including MACE) will be recorded at 6 hours, 30&#xD;
      days and 6 months after the procedure. At the 6-hour visit, patients will be assessed by a&#xD;
      medically-qualified investigator and have a blood sample collected for troponin T level and&#xD;
      ECG performed. At the 30-day visit, patients will receive a full clinical assessment by a&#xD;
      medically-qualified investigator, have DAPT compliance assessed, be asked about angina&#xD;
      intensity, have any MACE or other AEs recorded and have an ECG. A telephone contact will be&#xD;
      made at 6 months after PCI to assess any MACE or other AEs, angina intensity and DAPT&#xD;
      compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Delivery of equipment. PI not had any further interaction with the company so closed study.&#xD;
  </why_stopped>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma prothrombin fragments</measure>
    <time_frame>during the percutaneous coronary intervention procedure</time_frame>
    <description>Plasma prothrombin fragments 1+2 compared within-patients between samples from distal, mid and proximal ports</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fibrinopeptide A</measure>
    <time_frame>during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]</time_frame>
    <description>Compared with 0-6 hour serum hsTnT rise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble platelet P-selectin</measure>
    <time_frame>during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]</time_frame>
    <description>Compared with 0-6 hour serum hsTnT rise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TXB2</measure>
    <time_frame>during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]</time_frame>
    <description>Compared with 0-6 hour serum hsTnT rise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>platelet surface P-selectin expression</measure>
    <time_frame>during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]</time_frame>
    <description>Compared with 0-6 hour serum hsTnT rise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukocyte surface CD11b expression</measure>
    <time_frame>during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]</time_frame>
    <description>Compared with 0-6 hour serum hsTnT rise</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Non ST Segment Elevation Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>CE-marked coronary artery catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use of a novel CE-marked coronary artery catheter to obtain spatially-separated intravascular samples for laboratory measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Liquid Biopsy System</intervention_name>
    <description>The Liquid Biopsy System is a single use percutaneously-delivered coronary blood sampling device designed to collect blood samples from within a target coronary artery so that the blood can be analysed.</description>
    <arm_group_label>CE-marked coronary artery catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged over 18 years&#xD;
&#xD;
          -  Admitted to hospital with non-ST-elevation ACS and plan for either coronary&#xD;
             angiography with a view to PCI if appropriate or PCI following coronary angiography at&#xD;
             a referring hospital&#xD;
&#xD;
          -  Current treatment with aspirin and ticagrelor or, if ticagrelor is not tolerated,&#xD;
             prasugrel (DAPT)&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with antiplatelet medication apart from aspirin, ticagrelor, prasugrel or&#xD;
             clopidogrel in the last 10 days (e.g. dipyridamole, abciximab, tirofiban).&#xD;
&#xD;
          -  Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure.&#xD;
&#xD;
          -  Patients with haemodynamic instability, shock or angiographic evidence of&#xD;
             intracoronary thrombus.&#xD;
&#xD;
          -  Current use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban,&#xD;
             apixaban).&#xD;
&#xD;
          -  Clinically significant liver disease.&#xD;
&#xD;
          -  Contraindication or allergy to unfractionated heparin.&#xD;
&#xD;
          -  Receiving immunosuppressant medication (eg. cyclosporin, tacrolimus, mycophenolate,&#xD;
             azathioprine).&#xD;
&#xD;
          -  Administration of doses of low molecular weight heparin or fondaparinux in the 12&#xD;
             hours preceding PCI.&#xD;
&#xD;
          -  Known severe left ventricular dysfunction (ejection fraction &lt;30%).&#xD;
&#xD;
          -  Culprit lesion in left main coronary artery.&#xD;
&#xD;
          -  Women of childbearing potential unless pregnancy has been excluded during the index&#xD;
             hospital admission.&#xD;
&#xD;
          -  Known serum creatinine above upper limit of local reference range.&#xD;
&#xD;
          -  Subjects with known active chronic inflammatory disease, e.g. systemic lupus&#xD;
             erythematosus, rheumatoid arthritis, seropositive arthropathies and known&#xD;
             seropositivity to HIV, Hepatitis B or Hepatitis C.&#xD;
&#xD;
          -  Severely diseased, excessively tortuous or calcified coronary vessels that increase&#xD;
             the risk of snaring the LBS.&#xD;
&#xD;
          -  Culprit lesion in a coronary vessel with a reference diameter of less than 2.5 mm.&#xD;
&#xD;
          -  Need to cross a region of coronary vessel that contains a stent.&#xD;
&#xD;
          -  Evidence of ongoing sepsis.&#xD;
&#xD;
          -  Receiving a non-steroidal anti-inflammatory drug (NSAID) apart from aspirin, including&#xD;
             selective COX2 inhibitors ('coxibs') and including regular or intermittent/as required&#xD;
             use.&#xD;
&#xD;
          -  Receiving a strong inhibitor of CYP3A4 (eg, ketoconazole, itraconazole, voriconazole,&#xD;
             telithromycin, clarithromycin [but not erythromycin or azithromycin], nefazadone,&#xD;
             ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, or over 1 litre daily of&#xD;
             grapefruit juice).&#xD;
&#xD;
          -  Receiving simvastatin or lovastatin at doses higher than 40 mg daily.&#xD;
&#xD;
          -  Receiving a CYP3A substrate with a narrow therapeutic index (e.g. cyclosporine or&#xD;
             quinidine).&#xD;
&#xD;
          -  Receiving a strong inducer of CYP3A (e.g. rifampin/rifampicin, rifabutin, phenytoin,&#xD;
             carbamazepine, phenobarbital).&#xD;
&#xD;
          -  Current or recent (within 30 days) participation in a clinical trial of a drug or&#xD;
             device or any other clinical study that might influence the results or safety of the&#xD;
             study.&#xD;
&#xD;
          -  Any factor precluding ability to comply with follow-up.&#xD;
&#xD;
          -  Any other factor judged by the investigator or treating physician to preclude&#xD;
             enrolment in the 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>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
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    <citation>Timmermans PJ, Vossen JM. Prey catching in the archer fish: does the fish use a learned correction for refraction? Behav Processes. 2000 Oct 26;52(1):21-34. doi: 10.1016/s0376-6357(00)00107-8.</citation>
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    <citation>Suzuki N, Kato M, Dohmori R. [Synthesis of antimicrobial agents. II. Synthesis of 1,8-naphthyridine derivatives and their activities against Trichomonas vaginalis (author's transl)]. Yakugaku Zasshi. 1979 Feb;99(2):155-64. doi: 10.1248/yakushi1947.99.2_155. No abstract available. Japanese.</citation>
    <PMID>312317</PMID>
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    <citation>Lai Y, Xu DP. [Study on the chemical structure from the roots of Actinidia deliciosa]. Zhong Yao Cai. 2007 Feb;30(2):166-8. Chinese.</citation>
    <PMID>17571763</PMID>
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    <citation>[Animal husbandry (the main trends)]. Veterinariia. 1977 Jun;(6):LL'*23. No abstract available. Russian.</citation>
    <PMID>929940</PMID>
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    <citation>May A. The Confidential Enquiries into Maternal Deaths 1997-1999: what can we learn? Int J Obstet Anesth. 2002 Jul;11(3):153-5. doi: 10.1054/ijoa.2002.0957. No abstract available.</citation>
    <PMID>15321539</PMID>
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    <citation>Falgoust DL. Hospital security over the years: keeping up with the changes. J Healthc Prot Manage. 2002 Summer;18(2):115-22.</citation>
    <PMID>12371242</PMID>
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    <citation>da Costa MC. [Correlation between serum DDT levels and the diphtheria antibody titer in girls]. Rev Saude Publica. 1979 Mar;13(1):32-42. doi: 10.1590/s0034-89101979000100005. No abstract available. Portuguese.</citation>
    <PMID>223229</PMID>
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    <citation>Courtney LD. Respiratory distress syndrome. Br Med J. 1977 Mar 5;1(6061):639. doi: 10.1136/bmj.1.6061.639-a. No abstract available.</citation>
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    <citation>Farng E, Hunt SA, Rose DJ, Sherman OH. Anterior cruciate ligament radiofrequency thermal shrinkage: a short-term follow-up. Arthroscopy. 2005 Sep;21(9):1027-33. doi: 10.1016/j.arthro.2005.05.015.</citation>
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    <citation>Costa M, Pecci L, Pensa B, Cannella C. Hydrogen peroxide involvement in the rhodanese inactivation by dithiothreitol. Biochem Biophys Res Commun. 1977 Sep 23;78(2):596-603. doi: 10.1016/0006-291x(77)90221-2. No abstract available.</citation>
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    <citation>Mertz D, Johnstone J, Loeb M. Does duration of perioperative antibiotic prophylaxis matter in cardiac surgery? A systematic review and meta-analysis. Ann Surg. 2011 Jul;254(1):48-54. doi: 10.1097/SLA.0b013e318214b7e4.</citation>
    <PMID>21412147</PMID>
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    <citation>Zagury D, Chaouat G, Morgan DA, Voisin GA. [Identification of cytotoxic cells responsible for lysis of target cells pretreated with concanavalin A in spleen populations of pregnant mice with suppressive activity]. C R Seances Acad Sci D. 1979 May 7;288(17):1343-6. French.</citation>
    <PMID>113118</PMID>
  </reference>
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    <citation>Donnelly N, Hadwin JA, Cave K, Stevenage S. Perceptual dominance of oriented faces mirrors the distribution of orientation tunings in inferotemporal neurons. Brain Res Cogn Brain Res. 2003 Oct;17(3):771-80. doi: 10.1016/s0926-6410(03)00201-5.</citation>
    <PMID>14561462</PMID>
  </reference>
  <reference>
    <citation>Niederer RO, Zappulla DC. Refined secondary-structure models of the core of yeast and human telomerase RNAs directed by SHAPE. RNA. 2015 Feb;21(2):254-61. doi: 10.1261/rna.048959.114. Epub 2014 Dec 15. Erratum In: RNA. 2015 May;21(5):1053.</citation>
    <PMID>25512567</PMID>
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    <PMID>8691</PMID>
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    <citation>Pongrakhananon V, Luanpitpong S, Stueckle TA, Wang L, Nimmannit U, Rojanasakul Y. Carbon nanotubes induce apoptosis resistance of human lung epithelial cells through FLICE-inhibitory protein. Toxicol Sci. 2015 Feb;143(2):499-511. doi: 10.1093/toxsci/kfu251. Epub 2014 Nov 19.</citation>
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  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <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/NCT03300167
org study id: STH19267
nct id: NCT03300167
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This interventional study is using the PlaqueTec LBS will enrol participants already
      undergoing coronary angiography as a component of their standard care for NSTE-ACS. The study
      will involve no change to medication or overall treatment strategy, but will involve an
      additional procedure: use of a novel CE-marked coronary artery catheter to obtain
      spatially-separated intravascular samples for laboratory measurement. As a safety objective
      and as a component of the required post-marketing surveillance, OCT will be performed before
      and after deployment of the LBS, and patients will be followed up for a significant period of
      time by the investigator's post-procedure.

      Individual participants will not gain directly from taking part in the study, other than
      having access to more prolonged follow up than is standard. However, new insights will be
      gained into the microenvironment surrounding a ruptured plaque in NSTE-ACS, which has the
      potential to benefit patients with CAD in the future through greater understanding of the
      effects of current therapy, development of new treatment strategies and methods of assessing
      the efficacy of those treatment strategies.

      Use of the LBS and the associated OCT examinations will require additional angiographic
      screening and therefore lead to greater exposure to radiation and higher contrast load. This
      will be closely monitored as per Trust policies in line with IRMER and local radiological
      guidelines. Patients at particular risk of developing complications from increased exposure
      to radiation and contrast (eg. those who are pregnant and those with abnormal baseline renal
      function) will not be included in order to minimise adverse effects.
This clinical protocol will be subject to peer review according to standard local procedures,
      including independent scientific review by the Scientific Advisory Board of the Clinical
      Research Facility, Sheffield Teaching Hospitals NHS Foundation Trust; the Clinical Research
      Office, Sheffield Teaching Hospitals NHS Foundation Trust; and the Research Ethics Committee.
      The study will be a single-centre study including use of a CE-marked medical device to obtain
      samples, conducted at Cardiology and Cardiothoracic Surgery Directorate, Northern General
      Hospital, Sheffield Teaching Hospitals NHS Foundation Trust.

      Patients with a diagnosis of NSTE-ACS, receiving DAPT with a combination of aspirin and
      ticagrelor or prasugrel, and listed either for coronary angiography with the intention of
      proceeding to PCI or for PCI following coronary angiography at a referring hospital, will be
      approached and their informed consent sought for this study. 18 patients found to have
      culprit significant proximal epicardial coronary artery stenosis suitable for PCI, meeting
      all the inclusion and exclusion criteria, will proceed to have platelet function testing and
      LBS measurements. Blood will be taken from the arterial sheath or guide catheter and baseline
      platelet function testing will be performed (VerifyNow P2Y12 assay; light transmittance
      aggregometry with ADP and arachidonic acid as agonists; and serum thromboxane B2 assay).
      Balloon predilatation prior to stent deployment will be a mandatory requirement for the
      study. Following balloon predilatation, the LBS will be deployed across the treated lesion
      and blood sampling will be performed proximal and distal to the lesion at approximately 5
      minutes after predilatation. The following assays will be performed on the sampled blood:

        1. Plasma levels of soluble markers of thrombosis and inflammation including prothrombin
           fragments 1 and 2, fibrinopeptide A, soluble P-selectin and thromboxane B2.

        2. Platelet surface P-selectin expression

        3. Leukocyte surface CD11b expression Blood taken prior to PCI will also be sent to the
           local laboratory for measurement of the cardiac-specific marker high-sensitivity
           troponin T and a further venous blood sample will be collected at 6 hours after PCI to
           measure any rise in troponin in order to correlate this with thrombin generation. A rise
           of 5 times the upper limit of normal of troponin following PCI in the context of chest
           pain or diagnostic ECG changes will be used to define peri-procedural myocardial
           infarction per the Universal Definition of Myocardial Infarction (Thygesen, Alpert et
           al. 2012).

      OCT of the culprit lesion, as well as the coronary artery proximal and distal to this, will
      be performed before and after the deployment of the LBS to assess any topographical changes
      to the vessel wall caused by the LBS and provide information on target lesion morphology.

      Clinical outcomes will be reviewed and AEs (including MACE) will be recorded at 6 hours, 30
      days and 6 months after the procedure. At the 6-hour visit, patients will be assessed by a
      medically-qualified investigator and have a blood sample collected for troponin T level and
      ECG performed. At the 30-day visit, patients will receive a full clinical assessment by a
      medically-qualified investigator, have DAPT compliance assessed, be asked about angina
      intensity, have any MACE or other AEs recorded and have an ECG. A telephone contact will be
      made at 6 months after PCI to assess any MACE or other AEs, angina intensity and DAPT
      compliance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Plasma prothrombin fragments
time frame: during the percutaneous coronary intervention procedure
description: Plasma prothrombin fragments 1+2 compared within-patients between samples from distal, mid and proximal ports
measure: Fibrinopeptide A
time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
description: Compared with 0-6 hour serum hsTnT rise
measure: Soluble platelet P-selectin
time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
description: Compared with 0-6 hour serum hsTnT rise
measure: TXB2
time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
description: Compared with 0-6 hour serum hsTnT rise
measure: platelet surface P-selectin expression
time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
description: Compared with 0-6 hour serum hsTnT rise
measure: Leukocyte surface CD11b expression
time frame: during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]
description: Compared with 0-6 hour serum hsTnT rise
arm group label: CE-marked coronary artery catheter
arm group type: Experimental
description: use of a novel CE-marked coronary artery catheter to obtain spatially-separated intravascular samples for laboratory measurement.
intervention type: Device
intervention name: The Liquid Biopsy System
description: The Liquid Biopsy System is a single use percutaneously-delivered coronary blood sampling device designed to collect blood samples from within a target coronary artery so that the blood can be analysed.
arm group label: CE-marked coronary artery catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
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responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No