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This Clinical Study is a pivotal study to evaluate the safety of the SiteSealâ„¢ Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
The study design is a single arm with 90 patients. The primary endpoints measure the risk for common femoral nerve damage and common femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
The sample size is 90 patients. The project objective is to demonstrate the safety of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SiteSeal Endovascular | Other | After intervention (deployment and removal of the Site Seal endovascular adjunctive compression device), the physician determines whether or not there was laceration of the femoral nerve or laceration of the femoral artery per protocol. A series of possible minor and/or major complications are noted per protocol. There is a secondary metric as to patient reported pain on a 1-10scale. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SiteSeal Endovascular | Device | to evaluate the safety of the SiteSealâ„¢ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| The percent of patients with common femoral nerve damage or with bleeding from femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle. | Femoral damage is indicated if the patient has an audible response during suture placement. Arterial laceration is visible bleeding during suture placement. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-rated patient discomfort. | Patients are called back after 24 hours and asked to rate their discomfort on a 1-10 scale. The mean of all patients 1-10scale rating is reported as the discomfort of the arm. | 24 hour interview |
| The percent of patients who had a major complication. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elias Kassab, MD | MOVI | Principal Investigator |
| Matthew Earnest, MD | University of Kansas Medical Center | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2020 | |
| Reset | Jun 9, 2020 | |
| Release | Oct 14, 2020 | |
| Reset | Nov 4, 2020 | |
| Release | Nov 13, 2020 | |
| Reset | Dec 9, 2020 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2015 | Dec 13, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 12, 2015 | Dec 13, 2019 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2015 | Dec 13, 2019 | ICF_002.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2020 | Jun 9, 2020 | |||
| Oct 14, 2020 |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Major complications are defined in the protocol. Major complications are summed and the mean of the entire arm is reported as a percent of patients who had major complications. |
| 30day interview |
| The percent of patients who had a minor complication. | Minor complications are defined in the protocol. Minor complications are summed and the mean of the entire arm is reported as the percent of patients who had minor complications. | 30day interview |
| Nov 4, 2020 |
| Nov 13, 2020 | Dec 9, 2020 |