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| Name | Class |
|---|---|
| AccessClosure, Inc. | INDUSTRY |
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The Mynx Vascular Closure Device (Mynx M5) is a sponge-like material used to close the hole in the artery after patients undergo a diagnostic endovascular procedures
Key Inclusion:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Diagnostic Procedures | Device | Patients underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety & Tolerability | To assess safety and tolerability of participants ambulating within one hour of placement of the Mynx M5 Closure Device. Participants will be assessed for adverse event occurrence for 30 +/-7 days. | Enrollment approx for 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Assess device success, time to dischargeability, major and minor complications in all patients enrolled in the study | 30 +/- 7days |
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Inclusion Criteria:
Exclusion Criteria:
Pre-Procedure Exclusion Criteria
Intra-Procedure Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Vijay K Verma, MD | Cardiovascular Associates of the Delaware Valley | Principal Investigator |
| Mary F Kinder, RN, BSN | Cardiovascular Associates of the Delaware Valley | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady of Lourdes Medical Center | Camden | New Jersey | 08103 | United States |
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| ID | Term |
|---|---|
| D000792 | Angiography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D003935 |
| Diagnostic Techniques, Cardiovascular |