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Self-Centering Guide Catheter Feasibility Study

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ClinicalTrials.gov Identifier: NCT02639494
Recruitment Status : Completed
First Posted : December 24, 2015
Results First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE December 17, 2015
First Posted Date  ICMJE December 24, 2015
Results First Submitted Date  ICMJE May 31, 2017
Results First Posted Date  ICMJE August 29, 2018
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE May 12, 2016
Actual Primary Completion Date October 6, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle [ Time Frame: Through study completion, up to 72 hours post-procedure ]
This outcome will be assessed via physician determination and will be recorded in the case report form.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 27, 2018)
  • Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve [ Time Frame: Through study completion, up to 72 hours post-procedure ]
  • Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body [ Time Frame: Through study completion, up to 72 hours post-procedure ]
  • Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire [ Time Frame: Through study completion, up to 72 hours post-procedure ]
  • Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System [ Time Frame: Through study completion, up to 72 hours post-procedure ]
    The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form.
  • Number of Self-Centering Guide Catheters With Device Success [ Time Frame: Through study completion, up to 72 hours post-procedure ]
    Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system. This outcome will be assessed via physician determination and will be recorded in the case report form.
  • Number of Participants With Stroke [ Time Frame: 72 hours post-procedure ]
  • Number of Participants With Cardiac Tamponade [ Time Frame: 72 hours post-procedure ]
  • Death, All-cause, Cardiovascular, and Non-cardiovascular [ Time Frame: 72 hours post-procedure ]
  • Any Device-related Adverse Event [ Time Frame: 72 hours post-procedure ]
  • Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject [ Time Frame: 72 hours post-procedure ]
  • Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors [ Time Frame: 72 hours post-procedure ]
    All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-Centering Guide Catheter Feasibility Study
Official Title  ICMJE Self-Centering Guide Catheter Feasibility Study
Brief Summary An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
Detailed Description A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide Catheter. All subjects who are candidates for transcatheter aortic valve replacement (TAVR) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study. The Self-Centering Guide Catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Aortic Stenosis
Intervention  ICMJE Device: Self-Centering Guide Catheter
Study Arms  ICMJE Experimental: Self-Centering Guide Catheter
Subjects who provided written informed consent and an attempt is made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Intervention: Device: Self-Centering Guide Catheter
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2017)
20
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 6, 2016
Actual Primary Completion Date October 6, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
  • Subject is eligible for and is an acceptable candidate for transcatheter aortic valve replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg) native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques.

Exclusion Criteria:

  • Subject has known hypersensitivity to the components of the device (e.g., polyether block amide, fluoropolymers, nickel, platinum, tantalum, titanium).
  • Subject has a pre-existing prosthetic aortic valve.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 110 Years   (Adult, 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 NCT02639494
Other Study ID Numbers  ICMJE S2360
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rajiv Gulati, MD, PhD Mayo Clinic
PRS Account Boston Scientific Corporation
Verification Date August 2018

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