Aventus Thrombectomy System Pulmonary Embolism Clinical Study
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05907564 |
Recruitment Status :
Recruiting
First Posted : June 18, 2023
Last Update Posted : April 4, 2024
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Sponsor:
Inquis Medical, Inc.
Information provided by (Responsible Party):
Inquis Medical, Inc.
Tracking Information | |||||||
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First Submitted Date ICMJE | June 8, 2023 | ||||||
First Posted Date ICMJE | June 18, 2023 | ||||||
Last Update Posted Date | April 4, 2024 | ||||||
Actual Study Start Date ICMJE | September 20, 2023 | ||||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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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 | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Aventus Thrombectomy System Pulmonary Embolism Clinical Study | ||||||
Official Title ICMJE | Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism | ||||||
Brief Summary | Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism. | ||||||
Detailed Description | Not Provided | ||||||
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: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: Thrombectomy
Use of Aventus Thrombectomy System to treat pulmonary embolism
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Study Arms ICMJE | Experimental: Single Arm
Device: Aventus Thrombectomy System
Intervention: Device: Thrombectomy
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
120 | ||||||
Original Enrollment ICMJE | Not Provided | ||||||
Estimated Study Completion Date ICMJE | March 2025 | ||||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05907564 | ||||||
Other Study ID Numbers ICMJE | CT-0001 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Inquis Medical, Inc. | ||||||
Original Responsible Party | [Redacted] | ||||||
Current Study Sponsor ICMJE | Inquis Medical, Inc. | ||||||
Original Study Sponsor ICMJE | [Redacted] | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Inquis Medical, Inc. | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |