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The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON Atherectomy System, within the initial launch phase of the product in the market.
US multicenter, prospective, single-arm, observational post market Registry. A pilot registry aimed to evaluate the safety and efficacy of Auryon Atherectomy System in the treatment of de novo, re-stenotic and ISR lesions in infra-inguinal arteries of Peripheral Artery Diseases (PAD) subjects, in a real-world setting within the initial launch phase of the product in the market.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study patients | Eligible PAD patients who are routinely treated with atherectomy by AURYON Atherectomy System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AURYON Atherectomy System | Device | The AURYON Atherectomy System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy: Acute Procedural Success | Percentage of lesions with successful revascularization of target vessel defined as ≤30% residual stenosis at the treated lesion post Auryon atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab. | Peri-procedural (by the end of the index procedure) |
| Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE) | Percentage of subjects with freedom from peri-procedural major adverse events (PPMAE), defined as (a) flow-limiting dissection, (b) clinically significant distal embolization, (c) bailout stenting, (d) major/unplanned amputation, (e) target vessel perforation requiring endovascular or surgical repair or (f) death, till discharge. | Through discharge, an average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device Related Complications Requiring Intervention | Number of participants with device related complications requiring intervention, defined as peri procedural Major Adverse Events (MAEs), reported by the operating physician as caused directly due to the use of the AURYON device. | Till discharge, an average of 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with infra-inguinal PAD undergoing atherectomy with the AURYON Atherectomy System.
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| Name | Affiliation | Role |
|---|---|---|
| TBD TBD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulse Cardiovacular | Scottsdale | Arizona | 85259 | United States | ||
| Pima Vascular |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38566525 | Derived | Das TS, Shammas NW, Yoho JA, Martinez-Clark P, Ramaiah V, Leon LR, Pacanowski JP, Tai Z, Ali V, Arslan B, Rundback J. Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry. Catheter Cardiovasc Interv. 2024 May;103(6):949-962. doi: 10.1002/ccd.31023. Epub 2024 Apr 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Patients | Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System. AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system. The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions. |
| 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 | Oct 13, 2020 |
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| Number of Participants With Major Adverse Events (MAEs) Over Time | Number of participants with post-discharge MAEs over time; defined as: (a) Unplanned target limb amputation, (b) cardiovascular death, (c) clinically driven target lesion revascularization, (d) target vessel revascularization (TVR). | Post-discharge (at 30-days, 6-, 12-, and 24-months) |
| Number of Patent Lesions | Number of patent lesions, defined as <50% stenosis at the treated lesion, with peak systolic velocity ratio (PSVR) of <2.5, as assessed quantitatively by Duplex ultrasonography (DUS), at 6, 12, and 24 months. | Post-discharge (at 6-, 12-, and 24-months) |
| Freedom From Occlusion | Number of below-the-knee (BTK) lesions with freedom from occlusion (100% stenosis by DUS) combined with freedom from clinically-driven target lesion revascularization (CD-TLR) | Post-discharge (at 6-, 12-, and 24-months) |
| Change From Baseline in Ankle Brachial Index (ABI)/Tibial Brachial Index (TBI) | Change in ankle brachial index (ABI) or tibial brachial index (TBI) if ABI unavailable at 6, 12, and 24, months, compared to baseline. Ankle-Brachial Index (ABI) is an ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs and feet; 0.4-0.9 indicates mild-moderate peripheral artery disease (PAD); 0.4 and lower indicates severe PAD. Positive change between timepoints represents a clinical improvement over time. | Post-discharge (at 6-, 12-, and 24-months) |
| Change From Baseline in Walking Impairment Questionnaire (WIQ) | Change in walking impairment questionnaire (WIQ) score at 6, 12, and 24, months, compared to baseline. WIQ is a patient reported outcome (survey) to grade physical ability representing PAD progress. It has 3 sub-scales (walking speed, distance, climbing stairs), with the total score ranging between 0-100. A higher score means less impairment; positive change between timepoints represents a clinical improvement through time. | Post-discharge (at 6-, 12-, and 24-months) |
| Change From Baseline in Rutherford Clinical Category (RCC) | Change in Rutherford Clinical Category at 6, 12, and 24, months, compared to baseline. Rutherford Category is a physician-assessed measurement, with 7 stages (0= Asymptomatic to 6= Severe ischemic ulcers/frank gangrene) representing PAD progress. Lower value means less impairment. Positive difference between timepoints represents a clinical deterioration over time. | Post-discharge (at 6-, 12-, and 24-months) |
| Tucson |
| Arizona |
| 85718 |
| United States |
| Comprehensive Cardiovascular | Davenport | Florida | 33837 | United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32256 | United States |
| Amavita Clinical Research | Miami | Florida | 33169 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Midwest Cardio. research foundation | Davenport | Iowa | 52803 | United States |
| NJ Endovascular Amputation Prevention | Clifton | New Jersey | 07013 | United States |
| Medical City Heart and Spine | Dallas | Texas | 75243 | United States |
| Hurricane Cardiology | New Braunfels | Texas | 78130 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| ID | Title | Description |
|---|---|---|
| BG000 | Study Patients | Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System. AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system. The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions. |
| Units | Counts |
|---|---|
| Participants |
|
| Lesions |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| ||||||||||||||||||||
| Region of Enrollment | Number | participants | Participants |
|
| ||||||||||||||||||||
| Rutherford Category at baseline | Rutherford Category is a physician-assessed measurement, with 7 stages (0= Asymptomatic; 1= Mild claudication; 2= Moderate claudication; 3= Severe claudication; 4= Rest pain; 5= Ischemic ulceration not exceeding ulcer of the digits of the foot; 6= Severe ischemic ulcers or frank gangrene) representing PAD progress. Positive difference between timepoints represents a clinical deterioration over time. | Unavailable data for 1 participant out of the 102 | Mean | Standard Deviation | units on a scale | Participants |
| ||||||||||||||||||
| WIQ (Walking Impairment Questionnaire) at baseline | WIQ is a patient reported outcome (survey) to grade physical ability representing PAD progress. It has 3 sub-scales (walking speed, distance, climbing stairs), with the total score ranging between 0-100. A higher score means less impairment; positive change between timepoints represents a clinical improvement through time. | Unavailable data for 7 participants out of the 102 | Mean | Standard Deviation | units on a scale | Participants |
| ||||||||||||||||||
| ABI/TBI (Ankle/Toe Brachial Index) at baseline | ABI is calculated as the ratio of blood pressure in the ankle to the arm blood pressure. The normal value ranges between 0.9 to 1.3. An index under 0.90 means that blood is having a difficult time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. | Unavailable data for 34 participants out of the 102. | Mean | Standard Deviation | Ratio | Participants |
| ||||||||||||||||||
| Baseline % Stenosis of the target lesion (by Core laboratory) | Multiple lesions treated per patient | Mean | Standard Deviation | Percentage of Stenosis | Lesions |
|
| ||||||||||||||||||
| Baseline Calcification level at target lesion (core lab adjudicated) | Count of Units | Lesions | Lesions |
|
| ||||||||||||||||||||
| Target lesion length (by Core laboratory) | Mean | Full Range | Centimeter (cm) | Lesions |
|
|
| 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 | Primary Efficacy: Acute Procedural Success | Percentage of lesions with successful revascularization of target vessel defined as ≤30% residual stenosis at the treated lesion post Auryon atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab. | Angiography Core Lab-reported findings of Post Final Treatment (355 nm laser Target Lesion only). N=100 lesions in 88 subjects with available core lab stenosis post-final treatment. | Posted | Count of Units | Lesions | Peri-procedural (by the end of the index procedure) | Lesions | Lesions |
|
|
| ||||||||||||||||||||||||||
| Primary | Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE) | Percentage of subjects with freedom from peri-procedural major adverse events (PPMAE), defined as (a) flow-limiting dissection, (b) clinically significant distal embolization, (c) bailout stenting, (d) major/unplanned amputation, (e) target vessel perforation requiring endovascular or surgical repair or (f) death, till discharge. | Posted | Count of Participants | Participants | Through discharge, an average of 5 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Device Related Complications Requiring Intervention | Number of participants with device related complications requiring intervention, defined as peri procedural Major Adverse Events (MAEs), reported by the operating physician as caused directly due to the use of the AURYON device. | Posted | Count of Participants | Participants | Till discharge, an average of 5 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Events (MAEs) Over Time | Number of participants with post-discharge MAEs over time; defined as: (a) Unplanned target limb amputation, (b) cardiovascular death, (c) clinically driven target lesion revascularization, (d) target vessel revascularization (TVR). | Posted | Count of Participants | Participants | Post-discharge (at 30-days, 6-, 12-, and 24-months) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Patent Lesions | Number of patent lesions, defined as <50% stenosis at the treated lesion, with peak systolic velocity ratio (PSVR) of <2.5, as assessed quantitatively by Duplex ultrasonography (DUS), at 6, 12, and 24 months. | Number of lesions with DUS patency measured at each follow-up timepoint. | Posted | Count of Units | Lesions | Post-discharge (at 6-, 12-, and 24-months) | Lesions | Lesions |
| ||||||||||||||||||||||||||||
| Secondary | Freedom From Occlusion | Number of below-the-knee (BTK) lesions with freedom from occlusion (100% stenosis by DUS) combined with freedom from clinically-driven target lesion revascularization (CD-TLR) | Below-the-knee lesions only, with DUS measured at each follow-up timepoint | Posted | Count of Units | Lesions | No | Post-discharge (at 6-, 12-, and 24-months) | Lesions | Lesions |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Ankle Brachial Index (ABI)/Tibial Brachial Index (TBI) | Change in ankle brachial index (ABI) or tibial brachial index (TBI) if ABI unavailable at 6, 12, and 24, months, compared to baseline. Ankle-Brachial Index (ABI) is an ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs and feet; 0.4-0.9 indicates mild-moderate peripheral artery disease (PAD); 0.4 and lower indicates severe PAD. Positive change between timepoints represents a clinical improvement over time. | Patients with ABI/TBI available at both baseline and each follow-up timepoint. | Posted | Mean | Standard Deviation | Ratio | Post-discharge (at 6-, 12-, and 24-months) |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Walking Impairment Questionnaire (WIQ) | Change in walking impairment questionnaire (WIQ) score at 6, 12, and 24, months, compared to baseline. WIQ is a patient reported outcome (survey) to grade physical ability representing PAD progress. It has 3 sub-scales (walking speed, distance, climbing stairs), with the total score ranging between 0-100. A higher score means less impairment; positive change between timepoints represents a clinical improvement through time. | Patients with WIQ available at both baseline and each follow-up timepoint. | Posted | Mean | Standard Deviation | Score on a scale | Post-discharge (at 6-, 12-, and 24-months) |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Rutherford Clinical Category (RCC) | Change in Rutherford Clinical Category at 6, 12, and 24, months, compared to baseline. Rutherford Category is a physician-assessed measurement, with 7 stages (0= Asymptomatic to 6= Severe ischemic ulcers/frank gangrene) representing PAD progress. Lower value means less impairment. Positive difference between timepoints represents a clinical deterioration over time. | Patients with Rutherford Category available at both baseline and each follow-up timepoint. | Posted | Mean | Standard Deviation | Score on a scale | Post-discharge (at 6-, 12-, and 24-months) |
|
24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
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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 | Subjects Accountable for Safety | Adverse Events (AEs) over Time (Cumulative) - ITT population | 7 | 102 | 27 | 102 | 26 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Death | General disorders and administration site conditions | MedDRA 10.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders and administration site conditions | MedDRA 10.0 | Systematic Assessment |
| |
| Pain | General disorders and administration site conditions | MedDRA 10.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Device breakage | Product issues | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arterial revascularisation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Leg amputation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Stent placement | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral artery restenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vascular stent occlusion | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Medical device site haematoma | General disorders and administration site conditions | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | MedDRA 10.0 | Systematic Assessment |
| |
| Stenosis | General disorders and administration site conditions | MedDRA 10.0 | Systematic Assessment |
| |
| Ulcer | General disorders and administration site conditions | MedDRA 10.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Femoral artery dissection | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stent placement | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral artery dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oshrat Cohen | Angiodynamics | +972503222286 | oshrat.cohen@angiodynamics.com |
| Jan 23, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
| D007383 | Intermittent Claudication |
| D000089802 | Chronic Limb-Threatening Ischemia |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D007511 | Ischemia |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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Not provided
| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| Hispanic or Latino |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
|
|
|
|
| Title | Measurements |
|---|---|
| 0 - None |
|
| 1 - Focal |
|
| 2 - Mild |
|
| 3 - Moderate |
|
| 4 - Severe |
|
| Unknown |
|
| Title | Measurements |
|---|---|
|
|
|
| OG002 | 12 Months MAEs | Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
|
| OG003 | 24 Months MAEs | Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
|
|
|
| Units | Counts |
|---|
| Participants |
|
| Lesions |
|
|
| Lesions |
|
|
|
|
|
|
|
|