Self-Centering Guide Catheter Feasibility Study
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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: NCT02639494 |
Recruitment Status :
Completed
First Posted : December 24, 2015
Results First Posted : August 29, 2018
Last Update Posted : August 29, 2018
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Condition or disease | Intervention/treatment | Phase |
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Aortic Stenosis | Device: Self-Centering Guide Catheter | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | Self-Centering Guide Catheter Feasibility Study |
Actual Study Start Date : | May 12, 2016 |
Actual Primary Completion Date : | October 6, 2016 |
Actual Study Completion Date : | October 6, 2016 |

Arm | Intervention/treatment |
---|---|
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.
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Device: Self-Centering Guide Catheter |
- 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.
- 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

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Ages Eligible for Study: | 18 Years to 110 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639494
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Rajiv Gulati, MD, PhD | Mayo Clinic |
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT02639494 |
Other Study ID Numbers: |
S2360 |
First Posted: | December 24, 2015 Key Record Dates |
Results First Posted: | August 29, 2018 |
Last Update Posted: | August 29, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |