Trial record 1 of 1 for:
PK Papyrus (Humanitarian Use Device)
Treatment (Compassionate) Use of Device - PK Papyrus
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: NCT05436470 |
Expanded Access Status :
Temporarily not available
First Posted : June 29, 2022
Last Update Posted : June 27, 2023
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Sponsor:
University of Miami
Information provided by (Responsible Party):
Robert Starke, University of Miami
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Tracking Information | ||||
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First Submitted Date | June 21, 2022 | |||
First Posted Date | June 29, 2022 | |||
Last Update Posted Date | June 27, 2023 | |||
Descriptive Information | ||||
Brief Title | Treatment (Compassionate) Use of Device - PK Papyrus | |||
Official Title | Treatment (Compassionate) Use of Device - PK Papyrus | |||
Brief Summary | The purpose of this study is to evaluate the clinical use of the PK Papyrus Coronary Stent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under a Humanitarian Device Exemption. | |||
Detailed Description | Not Provided | |||
Study Type | Expanded Access | |||
Expanded Access Type | Individual Patients | |||
Condition |
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Intervention | Device: PK Papyrus
The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.
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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 | ||||
Expanded Access Status | Temporarily not available | |||
Eligibility Criteria | Inclusion Criteria: 1. Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery. Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT05436470 | |||
Other Study ID Numbers | 20220552 | |||
Current Responsible Party | Robert Starke, University of Miami | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor | University of Miami | |||
Original Study Sponsor | Same as current | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | University of Miami | |||
Verification Date | June 2023 |