Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02939976
Recruitment Status : Enrolling by invitation
First Posted : October 20, 2016
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
Medtronic Vascular
Volcano Corporation
Terumo Medical Corporation
Information provided by (Responsible Party):
David Kong, M.D., Duke University

Tracking Information
First Submitted Date  ICMJE October 18, 2016
First Posted Date  ICMJE October 20, 2016
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE August 30, 2017
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • Adjudicated 1-year infarct-related artery Major Adverse Cardiac and Cerebrovascular Event (MACE) [ Time Frame: 1 year ]
    Defined as cardiac death, infarct artery target-vessel MI, or ischemia-driven index infarct related vessel revascularization (IIVR) by percutaneous or surgical methods.
  • Adjudicated 1-year Complete versus Lesion-only Primary PCI trial (CvLPRIT) MACE [ Time Frame: 1 year ]
    Defined as all-cause mortality, recurrent MI, heart failure (requiring hospitalization or 12 hour ER visit) or ischemia-driven revascularization for all treated arteries.
  • Primary Observational Endpoint - Estimate of the incidence rate of Radial Artery Occlusion (RAO) [ Time Frame: During procedure ]
    Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
  • Primary Observational Endpoint - Estimate of the incidence rate of Radial Artery Occlusion (RAO) [ Time Frame: 30 day ]
    Stratified by whether or not the Terumo TR Band was employed (use of the TR Band is recommended not required)
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • Adjudicated 1-year infarct-related artery Major Adverse Cardiac and Cerebrovascular Event (MACE) [ Time Frame: 1 year ]
    Defined as cardiac death, infarct artery target-vessel MI, or ischemia-driven infarct artery target-vessel revascularization (TVR) by percutaneous or surgical methods
  • Adjudicated 1-year Complete versus Lesion-only Primary PCI trial (CvLPRIT) MACE [ Time Frame: 1 year ]
    Defined as all-cause mortality, recurrent MI, heart failure and ischemia-driven revascularization for all treated arteries.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • Adjudicated Death (all causes) [ Time Frame: Day 1 ]
    Efficacy endpoint
  • Adjudicated Death (all causes) [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Death (all causes) [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Cardiac Death [ Time Frame: Day 1 ]
    Efficacy endpoint
  • Adjudicated Cardiac Death [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Cardiac Death [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Nonfatal (re-) MI [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Nonfatal (re-) MI [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Index Infarct Related vessel (re-) MI [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Index Infarct Related vessel (re-) MI [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Index Infarct Related Lesion Revascularization (IILR) (ischemia driven) [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Index Infarct Related Lesion Revascularization (IILR) (ischemia driven) [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Index Infarct Vessel Revascularization (IIVR) (ischemia driven) [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Index Infarct Vessel Revascularization (IIVR) (ischemia driven) [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis [ Time Frame: Post-Procedure ]
    Safety endpoint
  • Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis [ Time Frame: 30 days ]
    Safety endpoint
  • Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis [ Time Frame: 1 year ]
    Safety endpoint
  • Adjudicated Academic Research Consortium (ARC) definite stent thrombosis [ Time Frame: Post-procedure ]
    Safety endpoint
  • Adjudicated Academic Research Consortium (ARC) definite stent thrombosis [ Time Frame: 30 days ]
    Safety endpoint
  • Adjudicated Academic Research Consortium (ARC) definite stent thrombosis [ Time Frame: 1 year ]
    Safety endpoint
  • Adjudicated stroke [ Time Frame: Post-procedure ]
  • Adjudicated stroke [ Time Frame: 30 days ]
  • Adjudicated stroke [ Time Frame: 1 year ]
  • Adjudicated Infarct Related vessel (re-P2) MI [ Time Frame: Day 1 ]
  • Adjudicated Infarct Related vessel (re-P2) MI [ Time Frame: 30 days ]
  • Heart failure (requiring hospitalization or 12 hour ER visit) [ Time Frame: Day 1 ]
  • Heart failure (requiring hospitalization or 12 hour ER visit) [ Time Frame: 30 days ]
  • Heart failure (requiring hospitalization or 12 hour ER visit) [ Time Frame: 1 year ]
  • Ischemia-driven revascularization for index infarct vessel revascularization (IIVR) or any treated index non-infarct related vessels (INIVR) [ Time Frame: 1 year ]
  • iFR guided revascularization - Site reported index hospitalization bleeding and vascular complication defined as bleeding or vascular co [ Time Frame: During procedure ]
  • iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - total procedure time [ Time Frame: During procedure ]
  • iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - total contrast used [ Time Frame: During procedure ]
  • iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - occurrence of renal insufficiency [ Time Frame: 48-72 hours post-procedure ]
  • iFR guided revascularization with Volcano based pressure wires Verrata®, Verrata Plus® and any subsequent marketed Volcano pressure wire technology - occurrence of renal insufficiency [ Time Frame: 30 days ]
  • Terumo TR Band - Site reported time to achieve hemostasis [ Time Frame: Post-procedure ]
    Secondary Observational Endpoint
  • Terumo TR Band - Incidence rate of cross over from the initial access point to another stratified by whether or not Terumo Slender GlideSheath was employed (use of the GlideSheath Slender is recommended not required) [ Time Frame: Day 1 ]
    Secondary Observational Endpoint
  • Terumo TR Band - Incidence rate of Access success defined as successfully deploying the stent through the right or left radial artery stratified by whether or not Terumo GlideSheath Slender was employed [ Time Frame: Day 1 ]
    Secondary Observational Endpoint
  • Terumo TR Band - incidence of RAO, stratified by whether or not the Terumo TR Band was employed in combination with GlideSheath Slender [ Time Frame: Day 1 ]
    Secondary Observational Endpoint
  • Terumo TR Band - incidence of RAO, stratified by whether or not the Terumo TR Band was employed in combination with GlideSheath Slender [ Time Frame: 30 days ]
    Secondary Observational Endpoint
  • Medtronic Resolute® Family of Stents - Site determination of Device success [ Time Frame: During index procedure ]
    Device performance endpoint
  • Medtronic Resolute® Family of Stents - Site determination of Lesion success [ Time Frame: During index procedure ]
    Device performance endpoint
  • Medtronic Resolute® Family of Stents - • Site determination of Procedure success [ Time Frame: During index procedure in-hospitalization ]
    Device performance endpoint
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • Site determination of stent Device success [ Time Frame: Within 30 days of index procedure ]
    Attainment of less than 20% residual stenosis of the target lesion at the time of the index procedure using only the study stent
  • Site determination of stent Lesion success [ Time Frame: Within 30 days of index procedure ]
    Attainment of less than 20% residual stenosis using any percutaneous method at the time of the index procedure
  • Site determination of stent Procedure success [ Time Frame: Within 30 days of index procedure ]
    Lesion success without the occurrence of in-hospital death, nonfatal MI, stroke, or emergency revascularization at the time of the index procedures
  • Adjudicated Death (all causes) [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Death (all causes) [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Death (all causes) [ Time Frame: 18 months ]
    Efficacy endpoint
  • Adjudicated Cardiac Death [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Cardiac Death [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Cardiac Death [ Time Frame: 18 months ]
    Efficacy endpoint
  • Adjudicated Nonfatal (re-) MI [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Nonfatal (re-) MI [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Nonfatal (re-) MI [ Time Frame: 18 months ]
    Efficacy endpoint
  • Adjudicated Target vessel (re-) MI [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Target vessel (re-) MI [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Target vessel (re-) MI [ Time Frame: 18 months ]
    Efficacy endpoint
  • Adjudicated Target Lesion revascularization (ischemia driven) [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Target Lesion revascularization (ischemia driven) [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Target Lesion revascularization (ischemia driven) [ Time Frame: 18 months ]
    Efficacy endpoint
  • Adjudicated Target Vessel revascularization (ischemia driven) [ Time Frame: 30 days ]
    Efficacy endpoint
  • Adjudicated Target Vessel revascularization (ischemia driven) [ Time Frame: 1 year ]
    Efficacy endpoint
  • Adjudicated Target Vessel revascularization (ischemia driven) [ Time Frame: 18 months ]
    Efficacy endpoint
  • Site reported target-lesion failure [ Time Frame: 30 days ]
    Efficacy endpoint
  • Site reported target-lesion failure [ Time Frame: 1 year ]
    Efficacy endpoint
  • Site reported target-lesion failure [ Time Frame: 18 months ]
    Efficacy endpoint
  • Adjudicated all cause mortality [ Time Frame: Post-procedure ]
    Death for any reason
  • Adjudicated all cause mortality [ Time Frame: 30 days ]
    Death for any reason
  • Adjudicated all cause mortality [ Time Frame: 1 year ]
    Death for any reason
  • Adjudicated all cause mortality [ Time Frame: 18 months ]
    Death for any reason
  • Adjudicated cardiac mortality [ Time Frame: Post-procedure ]
    Cardiac death only
  • Adjudicated cardiac mortality [ Time Frame: 30 days ]
    Cardiac death only
  • Adjudicated cardiac mortality [ Time Frame: 1 year ]
    Cardiac death only
  • Adjudicated cardiac mortality [ Time Frame: 18 months ]
    Cardiac death only
  • Adjudicated ARC definite/probable stent thrombosis [ Time Frame: Post-Procedure ]
  • Adjudicated ARC definite/probable stent thrombosis [ Time Frame: 30 days ]
  • Adjudicated ARC definite/probable stent thrombosis [ Time Frame: 1 year ]
  • Adjudicated ARC definite/probable stent thrombosis [ Time Frame: 18 months ]
  • Adjudicated ARC definite stent thrombosis [ Time Frame: Post-procedure ]
  • Adjudicated ARC definite stent thrombosis [ Time Frame: 30 days ]
  • Adjudicated ARC definite stent thrombosis [ Time Frame: 1 year ]
  • Adjudicated ARC definite stent thrombosis [ Time Frame: 18 months ]
  • Adjudicated (re-) MI [ Time Frame: Post-procedure ]
  • Adjudicated (re-) MI [ Time Frame: 30 days ]
  • Adjudicated (re-) MI [ Time Frame: 1 year ]
  • Adjudicated (re-) MI [ Time Frame: 18 months ]
  • Adjudicated stroke and TIA [ Time Frame: Post-procedure ]
  • Adjudicated stroke and TIA [ Time Frame: 30 days ]
  • Adjudicated stroke and TIA [ Time Frame: 1 year ]
  • Adjudicated stroke and TIA [ Time Frame: 18 months ]
  • Volcano iFR guided Complete Revascularization - Adjudicated Cardiovascular (CV) death [ Time Frame: Post-procedure ]
  • Complete Revascularization - Adjudicated Cardiovascular (CV) death [ Time Frame: 30 days ]
  • Complete Revascularization - Adjudicated Cardiovascular (CV) death [ Time Frame: 1 year ]
  • Complete Revascularization - Adjudicated CVA and TIA [ Time Frame: Post-procedure ]
  • Complete Revascularization - Adjudicated CVA and TIA [ Time Frame: 30 days ]
  • Complete Revascularization - Adjudicated CVA and TIA [ Time Frame: 1 year ]
  • Complete Revascularization - Site reported index hospitalization bleeding and vascular complications [ Time Frame: During procedure ]
  • Complete Revascularization - Total procedure time [ Time Frame: Post-procedure ]
  • Complete Revascularization - Total contrast used [ Time Frame: Post-procedure ]
  • Complete Revascularization - Occurrence of renal insufficiency [ Time Frame: 48-72 hours post-procedure ]
    Increase from baseline creatinine of at least 0.5 mg/dL, or at least 25%
  • Complete Revascularization - Occurrence of renal insufficiency [ Time Frame: 30 days ]
    Increase from baseline creatinine of at least 0.5 mg/dL, or at least 25%
  • Complete Revascularization - Occurrence of renal insufficiency [ Time Frame: 1 year ]
    Increase from baseline creatinine of at least 0.5 mg/dL, or at least 25%
  • Terumo Glidesheath Slender - Site reported index hospitalization bleeding or vascular complication requiring vascular repair [ Time Frame: During procedure ]
  • Terumo Glidesheath Slender - Site reported mild vascular spasm [ Time Frame: During procedure ]
    Spasm necessitates a delay in procedure or administration of anti-spasmodic medication
  • Terumo Glidesheath Slender - Site reported severe vascular spasm [ Time Frame: During procedure ]
    Spasm necessitates a change in access site or termination of the procedure
  • Terumo Glidesheath Slender - Site reported major sheath kinking [ Time Frame: During procedure ]
    Necessitates replacement of the sheath, a change in access site, or termination of the procedure
  • Terumo Glidesheath Slender - Site reported vascular access procedural success [ Time Frame: During procedure ]
    Defined as completion of the planned procedure through the radial access route without cross-over to femoral access
  • Terumo TR Band - Site reported time to achieve hemostasis [ Time Frame: Post-procedure ]
  • Terumo TR Band - Site reported access site re-bleeding following removal of TR Band [ Time Frame: Within 24 hours of index procedure ]
  • Terumo TR Band - Radial artery occlusion [ Time Frame: Acute ]
    Using Reverse Barbeau test
  • Terumo TR Band - Radial artery occlusion [ Time Frame: 30 days ]
    Using Reverse Barbeau test
  • Economic assessment US patients [ Time Frame: 1 year ]
    Total Medicare charges calculated for patients undergoing iFR-guided total revascularization versus IRA revascularization only
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
Official Title  ICMJE Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
Brief Summary

Patients with partially blocked blood vessel(s) in their heart may need a medical procedure called "Percutaneous Coronary Intervention (PCI)" to open the narrowed blood vessel(s). The purpose of this study is to simultaneously address four potential advances in ST-Elevation Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are looking to see if these advances can improve the outcome for these patients.

  1. Opening the arteries with a Medtronic stent
  2. Radial access (from wrist) success with a Medtronic stent
  3. Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
  4. Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI.
Detailed Description

Multicenter, randomized, open-label, unblinded, active and historical-controlled trial in which approximately 875 seniors undergoing urgent PCI from approximately 70 centers will be enrolled. All consented subjects will undergo attempted radial arterial access.

For DES (Drug Eluting Stent) eligible patients without randomization exclusion criteria and with multi-vessel disease identified during initial angiogram will be randomized by site in a ratio of 1:1 to IRA-only revascularization or iFR-guided complete revascularization. After randomization, subjects with stable TIMI-3 flow established in the IRA using the protocol specified treatment will proceed with the randomized procedure. Subjects in whom IRA reperfusion with TIMI-3 flow is not achieved will be treated according to clinical best practice standard of care independent of randomized procedure assignment and will not be considered protocol violations. These patients will be followed identically to all study patients.

After stent implantation, subjects will be contacted for follow-up at 30 days by the enrolling site and at 1 year by the DCRI Call Center.

Primary endpoint results will be reported after all subjects have completed 1 year (12 months) of clinical follow-up.

STEMI patients eligible for radial access:

  • DES Eligible with single vessel Coronary Artery Disease (CAD) will receive DES to IRA
  • DES Eligible with Multi-vessel CAD will randomize 1:1 to IRA-only revascularization or Instantaneous Wave Free Radio (iFR)-guided complete revascularization
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Device: Single Vessel Disease
    Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
  • Procedure: Multi-vessel Disease, Culprit Vessel Only
    Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
  • Procedure: Multi-vessel Disease, Complete Revascularization
    Complete revascularization of all diseased arteries
  • Device: Medtronic Resolute family of stents
    Revascularization with Medtronic Resolute family of stents in infarct related artery
  • Device: Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology
    Complete revascularization of all diseased arteries
  • Device: Terumo Glidesheath Slender
    Possible use of Terumo Glidesheath Slender
  • Device: Terumo TR Band Radial Compression Device
    Possible use of Terumo TR Band Radial Compression Device
Study Arms  ICMJE
  • Active Comparator: Single Vessel Disease
    Standard of care comparator for those subjects with single vessel coronary artery disease. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
    Interventions:
    • Device: Single Vessel Disease
    • Device: Medtronic Resolute family of stents
    • Device: Terumo Glidesheath Slender
    • Device: Terumo TR Band Radial Compression Device
  • Experimental: Multi-vessel Disease, Culprit Vessel Only
    Subjects randomized to revascularization of infarct related artery only. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
    Interventions:
    • Procedure: Multi-vessel Disease, Culprit Vessel Only
    • Device: Medtronic Resolute family of stents
    • Device: Terumo Glidesheath Slender
    • Device: Terumo TR Band Radial Compression Device
  • Experimental: Multi-vessel Disease, Complete Revascularization
    Subjects randomized to complete revascularization. Complete revascularization of all diseased arteries with Medtronic Resolute family of stents; Use of Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology to determine which arteries to stent; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
    Interventions:
    • Procedure: Multi-vessel Disease, Complete Revascularization
    • Device: Medtronic Resolute family of stents
    • Device: Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology
    • Device: Terumo Glidesheath Slender
    • Device: Terumo TR Band Radial Compression Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 17, 2017)
875
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
1100
Estimated Study Completion Date  ICMJE October 30, 2022
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Have the capacity to understand and sign an informed consent or have a Legally Authorized Representative that can understand and sign an informed consent prior to initial arteriotomy access.
  2. Age ≥ 65 years of age at the time of signing the informed consent and/or randomization.
  3. Significant ST-elevation myocardial infarction or left bundle branch block (LBBB) on ECG with chest pain < 12 hours.
  4. Accessible right or left radial artery conduit for PCI.
  5. Physician intent to perform trans-radial PCI.
  6. Willing to be contacted at 1 year by the DCRI Call Center

Study Randomization Inclusion Criteria

To be eligible for randomization in the 'IRA only vs. Complete Revascularization' phase of this trial, subjects must meet all of the above criteria and all of the following criteria subsequent to arterial access:

  1. Subject eligible for DES implantation.
  2. Angiographic multi-vessel CAD determined by local visual estimation.

Exclusion Criteria

  1. Patient that have known medical conditions that would prevent or interrupt the recommended post procedure DES treatment regimen.
  2. Patients that have known medical conditions that would prevent catheterization through the radial artery.
  3. Patients that have known medical conditions that increase patient's risk above standard when using IFR.
  4. Patients with a known history of Coronary Artery Bypass Grafting (CABG).
  5. Has had a cerebrovascular accident or transient ischemic neurological attack within the past 6 months.
  6. Known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol.
  7. Any condition associated with a life expectancy of less than 1 year.
  8. Participation in another clinical study using an investigational agent or device within the past 3 months.

Study Randomization Exclusion Criteria If a subject who has been consented into the SAFE STEMI study develops or is found to have any of the following, they will not be eligible for randomization to an iFR guided complete revascularization vs. IRA-only primary PCI and will be excluded from the study.

  1. Shock requiring pressors or mechanical circulatory assist support (IABP, Impella, ECMO, etc.) significant chronic renal disease (eGFR < 30) and/or on dialysis.
  2. Other angiographic exclusions:

    • Single vessel CAD
    • Unprotected left main coronary artery disease
    • One or more major coronary distributions with CTO or indeterminate IRA
  3. Clinical circumstances, which, in the judgment of the operator, preclude randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02939976
Other Study ID Numbers  ICMJE Pro00076262
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Kong, M.D., Duke University
Study Sponsor  ICMJE David Kong, M.D.
Collaborators  ICMJE
  • Medtronic Vascular
  • Volcano Corporation
  • Terumo Medical Corporation
Investigators  ICMJE
Principal Investigator: David F Kong, MD Duke University
Study Chair: Mitchell W Krucoff, MD Duke University
PRS Account Duke University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP