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| Name | Class |
|---|---|
| Veranex, Inc. | UNKNOWN |
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The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.
The purpose of the study is to demonstrate the safety and effectiveness of the AngioSafe Peripheral CTO Crossing System. The system facilitates the crossing of chronic total occlusions (CTOs) in the peripheral arteries of lower limbs. A minimum of 70 subjects will be treated across selected study enters within the U.S. and followed for 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AngioSafe Peripheral CTO Crossing System Procedure | Experimental | Use of AngioSafe Peripheral CTO Crossing System to facilitate the intraluminal placement of guidewires beyond Chronic Total Occlusions (CTOs) in the peripheral vasculature. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AngioSafe Peripheral CTO Crossing System | Device | The AngioSafe Peripheral CTO Crossing System is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including chronic total occlusions (CTOs) in the peripheral vasculature. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success of AngioSafe Peripheral CTO Crossing System | Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner. | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success of AngioSafe Peripheral CTO Crossing System | Technical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen. | Procedure, evaluated directly after performing the investigational procedure |
| Procedural Success of AngioSafe Peripheral CTO Crossing System |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Crossing Time, Mean | Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen. | Procedure, evaluated during the investigational procedure |
| Lesion Crossing Time, Median |
Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Subhash Banerjee, MD | North Texas Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health - Chandler Regional Medical Center | Chandler | Arizona | 85224 | United States | ||
| Adventist Health St. Helena |
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The study enrolled a total of 79 participants, with only 74 participants analyzed for effectiveness Outcome Measures. Study results (Outcome Measures) are reported for the 74 participants in the "Full Analysis Set (FAS)" Group described below. The 5 excluded participants are described in in other study Groups, excluded from effectiveness analyses, but included in the safety analyses (Adverse Event reporting).
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures | The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. These study participants are also included in the safety analysis of all (n=79) study participants. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2025 |
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Procedural Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen without a procedural complication within 30 days after the procedure. Procedural complication is defined as the need for open or repeat endovascular surgical repair in the treated limb, or a major bleeding event. |
| 30 Days |
| Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS). | Post-procedure IVUS evaluation of Technical Success cases to determine if crossing was performed intraluminally. | Procedure, evaluated directly after performing the investigational procedure |
| The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe). | Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner, analyzed by degree of calcification in two subgroups: None/Focal/Mild calcification, or Moderate/Severe calcification. | 24-hours |
Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen. |
| Procedure, evaluated during the investigational procedure |
| Rutherford Clinical Classification (RCC) Assessment | The mean change in the Rutherford Clinical Classification (RCC) assessment at 30 days versus baseline. The Rutherford Clinical Classification (RCC) Scale identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. The RCC Scale Categories and associated Clinical Descriptions are as follows: 0 - Asymptomatic, 1 - Mild claudication, 2- Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene. | Baseline, 30-days |
| Pain Numeric Rating Scale (NRS) Assessment | The mean change in Pain Numeric Rating Scale (NRS) assessment at 30-days versus baseline. The Pain Numeric Rating Scale (Pain NRS) is a unidimensional measure of pain intensity in adults. The NRS is anchored by terms describing pain severity extremes, where 0 represents no pain and 10 represents the worst pain possible. The NRS Ratings and associated Clinical Descriptions are as follows: 0 - No Pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-9 - Severe Pain, 10 - Worst Pain Possible. | Baseline, 30-days |
| St. Helena |
| California |
| 94754 |
| United States |
| Vascular Care Connecticut | Darien | Connecticut | 06820 | United States |
| Palm Vascular Centers | Miami Beach | Florida | 33140 | United States |
| Coastal Vascular & Interventional, PLLC | Pensacola | Florida | 32504 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52801 | United States |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States |
| Vascular Care Group | Wellesley | Massachusetts | 06820 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Mercy Hospital South | St Louis | Missouri | 63128 | United States |
| American Endovascular & Amputation Prevention | West Orange | New Jersey | 07052 | United States |
| Vascular Solutions of North Carolina | Cary | North Carolina | 27518 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Wellmont Cardiology Services | Kingsport | Tennessee | 37660 | United States |
| VA North Texas Medical Center | Dallas | Texas | 75216 | United States |
| Baylor Scott & White, The Heart Hospital Plano | Plano | Texas | 75093 | United States |
| Cardiovascular Associated of East Texas | Tyler | Texas | 75701 | United States |
| FG001 |
| Excluded Participants: Earlier Iteration of the Investigational Device |
N=4 study participants were excluded from the effectiveness analysis because they were enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the investigational device, whose use was discontinued early on in the study. These study participants are included in the safety analysis of all (n=79) study participants. |
| FG002 | Excluded Participant: Roll-In Subject | N=1 study participant was excluded from the effectiveness analysis because they were enrolled as a "roll-in" subject under a prior version of the Study Protocol. This study participant is included in the safety analysis of all (n=79) study participants. |
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| NOT COMPLETED |
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The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. The FAS population is the primary analysis population defined in the Study Protocol and is the only population with reported Baseline Characteristics analysis as pre-specified in the study Statistical Analysis Plan (SAP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures | The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. |
| 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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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Arterial Access Type | Twelve (12) participants had Secondary Arterial Access. | 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 | Clinical Success of AngioSafe Peripheral CTO Crossing System | Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner. | The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. | Posted | Count of Participants | Participants | 24 Hours |
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| Secondary | Technical Success of AngioSafe Peripheral CTO Crossing System | Technical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen. | The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. | Posted | Count of Participants | Participants | Procedure, evaluated directly after performing the investigational procedure |
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| Secondary | Procedural Success of AngioSafe Peripheral CTO Crossing System | Procedural Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen without a procedural complication within 30 days after the procedure. Procedural complication is defined as the need for open or repeat endovascular surgical repair in the treated limb, or a major bleeding event. | The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. | Posted | Count of Participants | Participants | 30 Days |
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| Secondary | Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS). | Post-procedure IVUS evaluation of Technical Success cases to determine if crossing was performed intraluminally. | Post-procedure IVUS evaluations were available for only 55 study participants from the Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. | Posted | Count of Participants | Participants | Procedure, evaluated directly after performing the investigational procedure |
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| Secondary | The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe). | Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner, analyzed by degree of calcification in two subgroups: None/Focal/Mild calcification, or Moderate/Severe calcification. | The Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version included 53 subjects with Moderate to Severe Calcification and 21 subjects with None to Mild Calcification | Posted | Count of Participants | Participants | 24-hours |
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| Other Pre-specified | Lesion Crossing Time, Mean | Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen. | Lesion crossing time was available for only 64 study participants from the Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. | Posted | Mean | Standard Error | min | Procedure, evaluated during the investigational procedure |
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| Other Pre-specified | Lesion Crossing Time, Median | Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen. | Lesion crossing time was available for only 64 study participants from the Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. | Posted | Median | 95% Confidence Interval | min | Procedure, evaluated during the investigational procedure |
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| Other Pre-specified | Rutherford Clinical Classification (RCC) Assessment | The mean change in the Rutherford Clinical Classification (RCC) assessment at 30 days versus baseline. The Rutherford Clinical Classification (RCC) Scale identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. The RCC Scale Categories and associated Clinical Descriptions are as follows: 0 - Asymptomatic, 1 - Mild claudication, 2- Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene. | The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. | Posted | Mean | Standard Error | RCC Scores on a scale | Baseline, 30-days |
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| Post-Hoc | Post-CTO-Crossing Track Dimensions: Width | Angiographic images were post-processed and analyzed to demonstrate angiographic visibility of intraplaque channel formation and to quantify the track width. | The Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version included n=55 participants with Technical Success (Outcome Measure 2), with angiographic imaging available for n=43 study participants. | Posted | Mean | Standard Deviation | mm | Procedure, evaluated directly after performing the investigational procedure |
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| Post-Hoc | Post-CTO-Crossing Track Dimensions: Diameter | Intravascular Ultrasounds (IVUS) images were post-processed and analyzed to demonstrate IVUS-confirmation of intraplaque channel formation and to quantify the track diameter. | The Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version included n=55 participants with Technical Success (Outcome Measure 2), with IVUS imaging available for n=44 study participants. | Posted | Mean | Standard Deviation | mm | Procedure, evaluated directly after performing the investigational procedure |
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| Post-Hoc | Post-CTO-Crossing Track Dimensions: Cross Sectional Area | Intravascular Ultrasounds (IVUS) images were post-processed and analyzed to demonstrate IVUS-confirmation of intraplaque channel formation, and to quantify the track dimensions. | The Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version included n=55 participants with Technical Success (Outcome Measure 2), with IVUS imaging available for n=44 study participants. | Posted | Mean | Standard Deviation | mm^2 | Procedure, evaluated directly after performing the investigational procedure |
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| Other Pre-specified | Pain Numeric Rating Scale (NRS) Assessment | The mean change in Pain Numeric Rating Scale (NRS) assessment at 30-days versus baseline. The Pain Numeric Rating Scale (Pain NRS) is a unidimensional measure of pain intensity in adults. The NRS is anchored by terms describing pain severity extremes, where 0 represents no pain and 10 represents the worst pain possible. The NRS Ratings and associated Clinical Descriptions are as follows: 0 - No Pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-9 - Severe Pain, 10 - Worst Pain Possible. | The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. | Posted | Mean | Standard Error | Pain NRS Scores on a scale | Baseline, 30-days |
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30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
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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 | All Study Participants | All study participants (n=79), including: n=74 participants treated the investigational device under the final Study Protocol version, n=4 participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the investigational device, and n=1 participant enrolled as a "roll-in" subject under a prior version of the Study Protocol, are included in safety analysis of Adverse Events. | 1 | 79 | 5 | 79 | 39 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ansel sheath complication | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Balloon failure | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 24.1 | Systematic Assessment | Death reported 3 days after the investigational procedure. Classified as not related to the investigational device or procedure. The cause of death was listed as "Hypertensive and Atherosclerotic Cardiovascular Disease" on the death certificate. |
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| Hypertension | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Pseudoaneurysm | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute digital ischemia | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Arterial blush | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Arterial dissection | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
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| Arterial perforation | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Rutherford Declines | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Edema | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Hematoma | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Hematuria | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Hypertension | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Hypotension | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Nausea | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Total occlusion | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Affairs | AngioSafe, Inc. | 8883479438 | info@angiosafe.com |
| Dec 22, 2025 |
| Prot_SAP_000.pdf |
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| 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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| Other, non-Hispanic |
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| White, non-Hispanic |
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| Missing |
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| Antegrade Femoral |
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| Pedal |
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| Popliteal |
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| Secondary Access |
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