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| ID | Type | Description | Link |
|---|---|---|---|
| Institutional Review Board | Other Identifier | The University of Tennessee Health Science Center |
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| Name | Class |
|---|---|
| Shockwave Medical, Inc. | INDUSTRY |
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The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)
This is a prospective randomized/control trial pilot study to compare clinical outcomes of common femoral artery access in patients undergoing TAVR at the University of Tennessee Medical. Specifically, This study compares patients utilizing the Shockwave model (M5) Intravascular Lithotripsy (IVL) prior to standard arterial access using the modified Seldinger technique to those utilizing the standard femoral artery access via the modified Seldinger approach without the utilization of intravascular lithotripsy in heavily calcified femoral arteries.
The secondary purposes of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shockwave model (M5) Intravascular Lithotripsy (IVL) | Experimental | Patients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique |
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| Standard femoral access | Active Comparator | Patients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave M5 IVL Catheter | Device | The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Determine need for Vascular surgery consultation | During hospital stay (Day 0-3) | |
| If vascular complication, was PTA, stenting, or open surgery used | During hospital stay (Day 0-3) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Medical Center | Recruiting | Knoxville | Tennessee | 37920 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2024 |
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| Modified Seldinger Technique | Procedure | Standard of care for femoral access in patients with calcified femoral arteries |
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| Modified Seldinger Technique | Procedure | Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification. |
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| Number of perclose devices used to close the femoral artery access site |
| During procedure (Day 0) |
| Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc | Within 3 days post-procedure |
| Change in Hemoglobin | As part of evaluating clinical deterioration, this outcome measures the drop in hemoglobin (g/dL) | Day 0 to Day 3 post-procedure |
| Change in Serum Creatinine | As part of evaluating clinical deterioration, this outcome assesses the increase in serum creatinine (mg/dL) | Day 0 to Day 3 post procedure |
| Incidence of Hypotension or Shock | As part of evaluating clinical deterioration, this outcome captures the number of participants who develop hypotension (SBP < 90 mmHg) or clinical shock. | Day 0 to Day 3 post-procedure |
| Incidence of Infections or Sepsis | As part of evaluating clinical deterioration, this outcome records the number of participants diagnosed with infection or sepsis | Day 0 to Day 3 post-procedure |
| Determine if there is a difference between hospital length of stay | Hospital length of stay will be measured in days from the date of admission to the date of discharge. The total duration will be compared between the intervention and control groups. | From date of admission to date of discharge, assessed up to 60 days |
| Assess for difference in pain/numbness in distal extremities post-procedure (Yes/No) | Within 3 days post-procedure |
| Assess for differences in mortality related to complications between the groups | Presence of new or worsening pain or numbness in the distal extremities will be assessed by patient-reported symptoms during routine clinical evaluation and physical examination. If present, symptoms will be documented in medical records | Up to 3 months post-procedure |
| Failure of treatment | Failure to achieve the intended procedural outcomes or additional interventions due to complications | Day 0 to discharge (or up to 3 days post-procedure) |
| Number of related AE(s) | Up to 3 months post-procedure |
| Number of related SAE(S) | Up to 3 months post-procedure |
| Side effects reported by subjects or observed by study team | Within 3 days post-procedure, or up to 3 months |
| Sep 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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