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| Name | Class |
|---|---|
| KCRI | OTHER |
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The aim of the study is to assess the safety and efficacy of the use of the Eximo's B-Laser™ catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity arteries.
This is a prospective, single-arm, multi-center, international, open-label, non-randomized clinical study.
All enrolled subjects will undergo atherectomy procedure, during which the B-Laser™ catheter will be used to perform atherectomy in target lesion, followed by any other adjunctive therapy (balloon and/or stent etc.). The procedure will be done according to standard hospital procedure for atherectomy. The steps of the operation before and after the operating of the B-Laser™ device are routinely used practice and will be done according to local practice at each hospital. For the post-atherectomy stage, as an adjunctive therapy in the procedure, any approved device may be used (balloon and/or stent etc.).
Subjects will then be followed for 12 months after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-Laser™ Atherectomy Catheter | Experimental | Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD), that the atherectomy part of the PTA will include an experimental atherectomy catheter, B-Laser™. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-Laser™ Atherectomy Catheter | Device | Laser atherectomy catheter based on 355 nm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 30 Day Freedom From Major Adverse Events |
| 30 days post procedure |
| Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1) | (*NOTE: Device- or procedure-related AE refers only to the ATHERECTOMY PROCEDURE (with B-Laser™) and not the entire index procedure.)
| Perioperative (until discharge), an average of 6 days |
| Number of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire. | The technical success will be evaluated visually by the performing physician during procedure by fluoroscopy. It is evaluated per lesion and not per subject | Intraoperative (during the index procedure, after B-Laser™ catheter crossing, before adjunctive therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2) | (*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.)
|
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Inclusion Criteria:
Intraoperative inclusion criteria (by fluoroscopy angiogram):
Exclusion Criteria:
Intraoperative exclusion criteria (by fluoroscopy angiogram):
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| Name | Affiliation | Role |
|---|---|---|
| Oshrat Cohen, Ph.D., MBA | Angiodynamics, Inc. | Study Director |
| Waclaw Kuczmik, Dr. | Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach | Principal Investigator |
| Grzegorz Oszkinis, Prof. | Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego | Principal Investigator |
| Lukasz Dzieciuchowicz, Prof | Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego | Principal Investigator |
| Lukasz Kruszyna, Prof | Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach | Katowice | 40635 | Poland | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | B-Laser™ Atherectomy Catheter | Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD) that the atherectomy part of the PTA includes an experimental atherectomy catheter, B-Laser™. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | B-Laser™ Atherectomy Catheter | Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD) that the atherectomy part of the PTA includes an experimental atherectomy catheter, B-Laser™. |
| 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 | Number of Participants With 30 Day Freedom From Major Adverse Events |
| Posted | Count of Participants | Participants | 30 days post procedure |
|
|
30 days, 6 months and 12 months post procedure with B-Laser™ device
If multiple terms (events) were coded within 1 reported event in eCRF, they were connected with '@' sign. E.g. LLT terms 'Upper gastrointestinal hemorrhage@Esophagitis@Gastroesophageal reflux disease' denotes the event description reported in eCRF: 'Upper gastrointestinal hemorrhage (mild) occurred on 15.03, resulted in hospitalization between 28-31.03. During hospital stay chest CT was done and endoscopic evaluation of upper GI tract, that revealed esophagitis, gastroesophageal reflux disease'.
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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 Catheter | Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD) that the atherectomy part of the PTA includes an experimental atherectomy catheter, B-Laser™. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | LLT and SOC MedDRA | Systematic Assessment | 329 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular dissection | Vascular disorders | LLT and SOC MedDRA | Systematic Assessment | 0 days post procedure. Not related to the Investigational Device. Definitely related to the index procedure. Minor dissection. |
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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 | Nov 20, 2016 | Jul 18, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Perioperative (until discharge), an average of 6 days |
| Number of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events | (*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.)
| 30 days post procedure |
| Number of Lesions With Post-intervention Residual Diameter Stenosis of <30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable | The ability of the B-Laser™ catheter to achieve a post-intervention residual diameter stenosis of <30% with adjunctive therapy assessed by fluoroscopic angiography in cases where adjunctive therapy is medically applicable | Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent) |
| Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline | Change in Ankle-Brachial Index (ABI) post B-Laser™ device procedure compared to baseline. ABI is calculated as the ratio of the ankle blood pressure to the arm blood pressure. The normal value ranges between 0.9 to 1.3. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher ABI score at the later time point represents an improvement through time and vice versa. | baseline and 30 days, 6 months and 12 months post procedure |
| Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline | Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline. Rutherford Classification has seven stages, from Stage 0 to Stage 6, when the lower value indicate 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. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent decrease while negative results represent increases, so lower Rutherford score at the later time point represents an improvement through time and vice versa. | baseline and 30 days, 6 months and 12 months post procedure |
| Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline | Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline. WIQ score ranges from 0-100 with higher score indicating a better walking outcomes. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher WIQ score at the later time point represents an improvement through time and vice versa. | baseline and 30 days, 6 months and 12 months post procedure |
| Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu |
| Poznan |
| 61848 |
| Poland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ABI (Ankle Brachial Index) | ABI is calculated as the ratio of the ankle blood pressure to the arm blood pressure. The normal value ranges between 0.9 to 1.3. Higher ABI score represents a better outcome | Mean | Standard Deviation | ratio |
|
| Participants |
|
|
| Primary | Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1) | (*NOTE: Device- or procedure-related AE refers only to the ATHERECTOMY PROCEDURE (with B-Laser™) and not the entire index procedure.)
| Posted | Count of Participants | Participants | Perioperative (until discharge), an average of 6 days |
|
|
|
| Primary | Number of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire. | The technical success will be evaluated visually by the performing physician during procedure by fluoroscopy. It is evaluated per lesion and not per subject | Generally angiographic outcomes are evaluated per lesions (53) and not per participants (50). Yet, this specific endpoint is analyzed for 52 lesions (instead of 53), since the data for this timepoint in one participant with one lesion was missing for evaluation of this specific endpoint. | Posted | Count of Units | lesions | Intraoperative (during the index procedure, after B-Laser™ catheter crossing, before adjunctive therapy) | lesions | lesions |
|
|
|
| Secondary | Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2) | (*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.)
| Posted | Count of Participants | Participants | Perioperative (until discharge), an average of 6 days |
|
|
|
| Secondary | Number of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events | (*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.)
| Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Secondary | Number of Lesions With Post-intervention Residual Diameter Stenosis of <30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable | The ability of the B-Laser™ catheter to achieve a post-intervention residual diameter stenosis of <30% with adjunctive therapy assessed by fluoroscopic angiography in cases where adjunctive therapy is medically applicable | This endpoint is analyzed for lesions (53) and not for participants (50) | Posted | Count of Units | lesions | Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent) | lesions | lesions |
|
|
|
| Secondary | Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline | Change in Ankle-Brachial Index (ABI) post B-Laser™ device procedure compared to baseline. ABI is calculated as the ratio of the ankle blood pressure to the arm blood pressure. The normal value ranges between 0.9 to 1.3. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher ABI score at the later time point represents an improvement through time and vice versa. | The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points | Posted | Mean | Standard Deviation | ratio | baseline and 30 days, 6 months and 12 months post procedure |
|
|
|
| Secondary | Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline | Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline. Rutherford Classification has seven stages, from Stage 0 to Stage 6, when the lower value indicate 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. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent decrease while negative results represent increases, so lower Rutherford score at the later time point represents an improvement through time and vice versa. | The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points | Posted | Count of Participants | Participants | baseline and 30 days, 6 months and 12 months post procedure |
|
|
|
| Secondary | Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline | Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline. WIQ score ranges from 0-100 with higher score indicating a better walking outcomes. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher WIQ score at the later time point represents an improvement through time and vice versa. | The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points. Answers to all questions in the Walking Impairment Questionnaire (WIQ) must be provided to obtain a valid result, incomplete questionnaires were not considered. | Posted | Mean | Standard Deviation | score on a scale | baseline and 30 days, 6 months and 12 months post procedure |
|
|
|
| Post-Hoc | Number of Lesions With Post-intervention Residual Diameter Stenosis of ≤30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable | EX-PAD-01 study secondary efficacy endpoint of the post adjunctive therapy residual diameter stenosis, was set per protocol with a threshold at <30%, however, in many other atherectomy studies, this threshold is set at ≤30%, Therefore results with this threshold are presented as well | This endpoint is analyzed for lesions (53) and not for participants (50) | Posted | Count of Units | lesions | Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent) | lesions | lesions |
|
|
|
| 0 |
| 46 |
| 14 |
| 46 |
| 15 |
| 46 |
|
| Heart Failure | Cardiac disorders | LLT and SOC MedDRA | Systematic Assessment | 144 & 356 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Chronic ischemic heart disease, unspecified | Cardiac disorders | LLT and SOC MedDRA | Systematic Assessment | 82 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Non STEMI@Atrioventricular block@Cardiogenic shock@Acute renal failure | Cardiac disorders | LLT and SOC MedDRA | Systematic Assessment | 322 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
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| Rectal hemorrhage | Gastrointestinal disorders | LLT and SOC MedDRA | Systematic Assessment | 8 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Large intestine angiodysplasia | Gastrointestinal disorders | LLT and SOC MedDRA | Systematic Assessment | 126 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Upper gastrointestinal hemorrhage@ Esophagitis@ Gastroesophageal reflux disease | Gastrointestinal disorders | LLT and SOC MedDRA | Systematic Assessment | 92 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Vascular access site hematoma | Injury, poisoning and procedural complications | LLT and SOC MedDRA | Systematic Assessment | 0 days post procedure. Not related to the Investigational Device. Causal relationship to the index procedure. |
|
| Superficial femoral arterial stenosis & Claudication@Leg ischemia@Disease progression | Vascular disorders | LLT and SOC MedDRA | Systematic Assessment | 8 & 197 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Leg ischemia@Superficial femoral arterial stenosis@Claudication | Vascular disorders | LLT and SOC MedDRA | Systematic Assessment | 384 days post procedure. Not related to the Investigational Device. Possibly related to the index procedure. |
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| Non STEMI@ Bradycardia | Cardiac disorders | LLT and SOC MedDRA | Systematic Assessment | 319 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Angina pectoris unstable | Cardiac disorders | LLT and SOC MedDRA | Systematic Assessment | 308 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Atrial fibrillation | Cardiac disorders | LLT and SOC MedDRA | Systematic Assessment | 319 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Leg ischemia@ Popliteal arterial restenosis | Vascular disorders | LLT and SOC MedDRA | Systematic Assessment | 245 days post procedure. Might be related to both device or Index procedure and judged to be more due to Index procedure. |
|
| Intracranial hemorrhage | Nervous system disorders | LLT and SOC MedDRA | Systematic Assessment | 232 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
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| Arterial occlusion | Vascular disorders | LLT and SOC MedDRA | Systematic Assessment | 163 days post procedure. Not related to the Investigational Device. Related to the index procedure. |
|
| Pseudoaneurysm | Injury, poisoning and procedural complications | LLT and SOC MedDRA | Systematic Assessment | 0 days post procedure. Not related to the Investigational Device. Definitely related to the index procedure. |
|
| Leg ischemia@Superficial femoral arterial stenosis | Vascular disorders | LLT and SOC MedDRA | Systematic Assessment | 195 & 207 & 221 & 324 days post procedures. Not related to the Investigational Device. Probably not related to the index procedure. |
|
| Leg ischemia | Vascular disorders | LLT and SOC MedDRA | Systematic Assessment | 188 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Claudication | Vascular disorders | LLT and SOC MedDRA | Systematic Assessment | 31 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Nasal bleeding | Respiratory, thoracic and mediastinal disorders | LLT and SOC MedDRA | Systematic Assessment | 20 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Hyperglycemia | Metabolism and nutrition disorders | LLT and SOC MedDRA | Systematic Assessment | 287 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Skin infection | Infections and infestations | LLT and SOC MedDRA | Systematic Assessment | 180 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
|
| Edema lower limb | General disorders | LLT and SOC MedDRA | Systematic Assessment | 4 & 28 days post procedure. Not related to the Investigational Device. Not related to the index procedure. |
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|
| 6 months |
|
|
| 12 months |
|
|
| Rutherford class 2 |
|
| Rutherford class 3 |
|
| Rutherford class 4 |
|
| 30 days |
|
|
| 6 months |
|
|
| 12 months |
|
|
|
| 6 months |
|
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| 12 months |
|
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