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The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diamondback 360 Extended Length Orbital Atherectomy System | Device | All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success: | Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm. | Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success: | Treatment success is defined as <50% residual stenosis post-procedure and without significant angiographic complications without stent placement, or <30% residual stenosis post-procedure and without significant angiographic complications with stent placement. | Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours |
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Inclusion Criteria:
Index Procedure Inclusion Criteria:
Exclusion Criteria:
Index Procedure Exclusion Criteria
Physician unable to obtain radial artery access
Physician determines TRA is not acceptable due to patient anatomy, lesion characteristics, and/or disease severity
OAS use not attempted (defined as ViperWire introduced into the body)
Prior to insertion of ViperWire:
Femoral access is obtained
Unsuccessful peripheral intervention
A reportable adverse event has occurred
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All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cardiovascular Research Center | Phoenix | Arizona | 85016 | United States | ||
| Arkansas Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34020900 | Result | Lodha A, Giannopoulos S, Sumar R, Ratcliffe J, Gorenchtein M, Green P, Rollefson W, Stout CL, Armstrong EJ. Transradial Endovascular Intervention: Results From the Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention (REACH PVI) Study. Cardiovasc Revasc Med. 2022 Mar;36:115-120. doi: 10.1016/j.carrev.2021.05.011. Epub 2021 May 15. |
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Following physician assessment of patient and general inclusion/exclusion and informed consent signature, subjects were eligible for enrollment pending index procedure inclusion and exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | OAS Use Via Transradial Access (TRA) | All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2019 | Feb 3, 2021 |
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| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Cardiovascular Institute of the South - Lafayette General South West OBL | Lafayette | Louisiana | 70506 | United States |
| Mercy Hospital, Springfield | Chesterfield | Missouri | 63017 | United States |
| Columbia University Medical Center/New York Presbyterian | New York | New York | 10032 | United States |
| Sorin Medical, P.C. | New York | New York | 10065 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | OAS Use Via Transradial Access (TRA) | All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline Rutherford Clinical Category | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Procedural Success: | Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm. | Posted | Count of Participants | Participants | Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure) |
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| Secondary | Treatment Success: | Treatment success is defined as <50% residual stenosis post-procedure and without significant angiographic complications without stent placement, or <30% residual stenosis post-procedure and without significant angiographic complications with stent placement. | Posted | Count of Participants | Participants | Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours |
|
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The reporting of adverse events (AEs) began immediately after the subject was enrolled through the first standard of care follow-up visit (7 - 45 days post-procedure). For the purposes of this study, pre-planned interventions noted at baseline were not considered reportable AEs.
Adverse events were limited to: SAEs, TRA Related Events, Significant Angiographic Events and OAS and ViperCath device related serious injuries. The reporting of AEs began immediately after the subject was enrolled through study exit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OAS Use Via Transradial Access (TRA) | All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion. | 0 | 50 | 2 | 50 | 0 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Extremity Disorders | Vascular disorders | Systematic Assessment | Peripheral artery restenosis |
| |
| Procedural Complications, Lower Extremities | Injury, poisoning and procedural complications | Systematic Assessment | Peripheral artery restenosis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Manager | Cardiovascular Systems Inc. | 651.259.2500 | clinicaltrials_csi@csi360.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2019 | Feb 3, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| Unknown or Not Reported |
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| White |
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| Other |
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| Unknown or Not Reported |
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| Ischemic Rest Pain (4) |
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| Minor Tissue Loss (5) |
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