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This is a prospective, single-arm, multi-center, international, open-label, clinical study.
The aim of the study is to assess the safety and efficacy of the Eximo Medical's B-Laser™ Atherectomy catheter in subjects with infrainguinal Peripheral Artery Disease (PAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-Laser™ Atherectomy System | Experimental | B-Laser™ Atherectomy System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-Laser™ Atherectomy System | Device | The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Technical Success | Reduction from baseline in residual diameter stenosis (%), prior to any adjunctive therapy, achieved by the B-Laser™ catheter A change (always a reduction) between two time points (baseline time-point and post B-Laser treatment time-point, both perioperative) is reported:
| Perioperative |
| Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs) |
| 30 (+/-5) days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target Vessel |
|
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Inclusion Criteria:
Intraoperative inclusion criteria (by fluoroscopy angiogram):
Target lesion has a stenosis estimated to be ≥70%.
In ATK subjects - at least one patent tibial run-off vessel into the foot
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Exclusion Criteria:
Intraoperative exclusion criteria (by fluoroscopy angiogram):
Inability to intraluminally cross and secure a 0.014" wire across the target lesion.
Target lesion length <1cm and >15 cm (in ISR cases >25cm).
Reference vessel lumen diameter proximal to target lesion is <150% of the outer diameter of the B-LaserTM.
Any clinical and/or angiographic complication prior to the planed insertion of B-laser™.
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| Name | Affiliation | Role |
|---|---|---|
| John Rundback, Dr. | Holy Name Medical Center, Teaneck, New Jersey, United States, 07666 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Heart | Little Rock | Arkansas | 72211 | United States | ||
| Orlando Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | B-Laser™ Atherectomy System | B-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | B-Laser™ Atherectomy System | B-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Acute Technical Success | Reduction from baseline in residual diameter stenosis (%), prior to any adjunctive therapy, achieved by the B-Laser™ catheter A change (always a reduction) between two time points (baseline time-point and post B-Laser treatment time-point, both perioperative) is reported:
| Unavailable angiographic data for primary efficacy endpoint analysis for 2 participants with 2 lesions out of the 97 participants with 109 lesions (these 2 were considered ITT and not PP). | Posted | Mean | Standard Deviation | Change in RDS (%) | Perioperative | lesions | lesions |
|
6 months (+/-14 days) post procedure
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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 | B-Laser™ Atherectomy System | B-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorders | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oshrat Cohen | Eximo Medical | 97286307639 | oshratc@eximomedical.com |
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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 2, 2017 | Feb 24, 2019 | Prot_SAP_000.pdf |
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| Perioperative and up to 30 (+/-5) days post procedure |
| Number of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target Vessel |
| Perioperative and up to 30 (+/-5) days post procedure |
| Number of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection. | Number of Lesions with residual stenosis by angiography of ≤ 30% post-procedure including any adjunctive therapy, with no flow limiting dissection. * As assessed quantitatively by the core laboratory. | Perioperative |
| PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1) |
| 30 (+/-5) days post procedure |
| PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2) | c) Ankle-Brachial Index (ABI): 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 & feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa. | 30 (+/-5) days post procedure |
| Number of Lesions With Clinical Success at 30 Days | Defined as < 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is < 2.5. * As assessed quantitatively by the core laboratory. | 30 (+/-5) days post procedure |
| Altamonte Springs |
| Florida |
| 32714 |
| United States |
| Cardiovascular solutions institute, Blake MC | Bradenton | Florida | 34208 | United States |
| North Florida Regional Medical Center | Gainesville | Florida | 32605 | United States |
| UnityPoint Trinity Bettendorf , Genesis Health System | Davenport | Iowa | 52803 | United States |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
| Medical University Graz | Graz | 8036 | Austria |
| Policlinico Abano Terme | Abano Terme | 35031 | Italy |
| Maria Cecilia Hospital | Cotignola | 48033 | Italy |
| Lesions |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Rutherford class at baseline | Rutherford Classification is determined by the physician and represents the progress of the peripheral artery disease. It has seven stages, from Stage 0 to Stage 6, when the lower value indicates a better outcome: 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. | Mean | Standard Deviation | scores on a scale | Participants |
|
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| WIQ (Walking Impairment Questionnaire) at baseline | WIQ is a patient fulfilled survey reporting the grade of ones physical activities ability to represent the progress of the peripheral artery disease. It has few subscales (walking speed, distance, climbing stairs), when the total score of this survey ranges between 0 (worst) and 100 (best), and the higher value = the better outcome. | Unavailable data for 4 participants out of the 97. | Mean | Standard Deviation | scores on a scale | Participants |
|
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| ABI (Ankle 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 9 participants out of the 97. | Mean | Standard Deviation | ratio | Participants |
|
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| Baseline Stenosis % at target lesion (by Core laboratory) | Mean | Standard Deviation | % | Lesions |
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| Baseline Stenosis % at target lesion (by Core laboratory) | Count of Units | Lesions | Lesions |
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| Baseline Calcification level at target lesion (by Core laboratory) | Count of Units | Lesions | Lesions |
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| Target lesion length (by Core laboratory) | Mean | Full Range | cm | Lesions |
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| Primary | Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs) |
| 1 Cardiovascular related death was unrelated to the device per the CEC. Four participants out of the 97 with unavailable data: two were lost to follow-up before the 30-day visit was completed, and two others had their 30-day visit outside of the allowable window (day 16 and day 23). | Posted | Count of Participants | Participants | 30 (+/-5) days post procedure |
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| Secondary | Number of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target Vessel |
| Posted | Count of Units | lesions | Perioperative and up to 30 (+/-5) days post procedure | lesions | lesions |
|
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| Secondary | Number of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target Vessel |
| All the 16 cases were type A (11) and B (5) dissections only. No perforations, major dissections, emboli or pseudoaneurysm. | Posted | Count of Units | lesions | Perioperative and up to 30 (+/-5) days post procedure | lesions | lesions |
|
|
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| Secondary | Number of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection. | Number of Lesions with residual stenosis by angiography of ≤ 30% post-procedure including any adjunctive therapy, with no flow limiting dissection. * As assessed quantitatively by the core laboratory. | Unavailable data for primary efficacy endpoint analysis for 2 participants out of the 97. | Posted | Count of Units | lesions | Perioperative | lesions | lesions |
|
|
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| Secondary | PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1) |
| Only available data for comparison at the two time-points is presented for each parameter . | Posted | Mean | Standard Error | scores on a scale | 30 (+/-5) days post procedure |
|
|
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| Secondary | PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2) | c) Ankle-Brachial Index (ABI): 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 & feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa. | Only available data for comparison at the two time-points is presented for each parameter . | Posted | Mean | Standard Error | ratio | 30 (+/-5) days post procedure |
|
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| Secondary | Number of Lesions With Clinical Success at 30 Days | Defined as < 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is < 2.5. * As assessed quantitatively by the core laboratory. | Unavailable PSVR for 13 participants (14 lesions) from 95 participants (107 lesions): 5 participants (6 lesions) not diagnostic due to technical incompliance at exam; 3 participants (3 lesions) lost to follow-up; 1 participant (1 lesion) died; 4 participants (4 lesions), core lab could not calculate PSVR, yet were considered patent by absolute PSV. | Posted | Count of Units | lesions | 30 (+/-5) days post procedure | lesions | lesions |
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| Post-Hoc | Number of Participants With Freedom From 6 Months Major Adverse Events (MAEs) [Not a Study Pre-specified Endpoint] |
| 3 CD-TLRs were possibly related to device & definitely related to index procedure, per CEC. 8 participants out of total 97 with unavailable data: 3 subjects were lost to follow-up before 6-month visit was completed, 1 subject died before 6-month visit, and 3 other subjects had their 6-month visit outside of the allowable window (before Day 166). | Posted | Count of Participants | Participants | 6 months (+/-14 days) post procedure |
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| Post-Hoc | PAD Measurements at the 6-month Visit Post-procedure Compared to Baseline [Not a Study Pre-specified Endpoint] (1) |
| Only available data for comparison at the two time-points is presented for each parameter . | Posted | Mean | Standard Error | score on a scale | 6-month (+/-14 days) post-procedure |
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| Post-Hoc | PAD Measurements at the 6-month Visit Post-procedure Compared to Baseline [Not a Study Pre-specified Endpoint] (2) | c) Ankle-Brachial Index (ABI): 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 & feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa. | Only available data for comparison at the two time-points is presented for each parameter . | Posted | Mean | Standard Error | ratio | 6-month (+/-14 days) post-procedure |
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| Post-Hoc | Number of Lesions With 6-Month Patency [Not a Study Pre-specified Endpoint] | Defined as < 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is < 2.5. * As assessed quantitatively by the core laboratory. This is not a study pre-specified endpoint. | Unavailable PSVR for 14 participants (17 lesions) from 95 participants (107 lesions): 3 participants (4 lesions) not diagnostic due to technical incompliance at exam; 5 participants (5 lesions) lost to follow-up; 2 participants (3 lesions) died; 4 participants (5 lesions), core lab could not calculate PSVR. | Posted | Count of Units | lesions | 6 months (+/-14 days) post procedure | lesions | lesions |
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| 2 |
| 93 |
| 43 |
| 93 |
| 54 |
| 93 |
| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
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| General disorders | General disorders | Systematic Assessment |
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| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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