Self-Centering Guide Catheter Feasibility Study

• 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: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Tracking Information

• First Submitted Date: December 17, 2015
• First Posted Date: December 24, 2015
• Results First Submitted Date: May 31, 2017
• Results First Posted Date: August 29, 2018
• Last Update Posted Date: August 29, 2018
• Actual Study Start Date: May 12, 2016
• Actual Primary Completion Date: October 6, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: 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: Self-Centering Guide Catheter Feasibility Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Device Feasibility
• Condition: Aortic Stenosis
• Intervention: Device: Self-Centering Guide Catheter

Study Arms

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 29, 2017): 20
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 6, 2016
• Actual Primary Completion Date: October 6, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 110 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02639494
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Boston Scientific Corporation
• Study Sponsor: Boston Scientific Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rajiv Gulati, MD, PhD; Mayo Clinic

• PRS Account: Boston Scientific Corporation
• Verification Date: August 2018