Trial Outcomes & Findings for Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment (NCT NCT02556255)
NCT ID: NCT02556255
Last Updated: 2021-03-03
Results Overview
1. Need for emergency surgical revascularization of the target limb 2. Unplanned target limb amputation above the ankle 3. Clinically driven Target Lesion Revascularization (TLR) 4. Cardiovascular related deaths
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
30 days post procedure
Results posted on
2021-03-03
Participant Flow
Participant milestones
| Measure |
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™.
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|---|---|
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Overall Study
STARTED
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50
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Overall Study
COMPLETED
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46
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
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™.
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|---|---|
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Overall Study
Lost to Follow-up
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4
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
B-Laser™ Atherectomy Catheter
n=50 Participants
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™.
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|---|---|
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Age, Continuous
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64 years
STANDARD_DEVIATION 8.5 • n=50 Participants
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Sex: Female, Male
Female
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12 Participants
n=50 Participants
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Sex: Female, Male
Male
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38 Participants
n=50 Participants
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ABI (Ankle Brachial Index)
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0.57 ratio
STANDARD_DEVIATION 0.14 • n=50 Participants
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PRIMARY outcome
Timeframe: 30 days post procedure1. Need for emergency surgical revascularization of the target limb 2. Unplanned target limb amputation above the ankle 3. Clinically driven Target Lesion Revascularization (TLR) 4. Cardiovascular related deaths
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=50 Participants
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™.
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|---|---|
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Number of Participants With 30 Day Freedom From Major Adverse Events
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50 Participants
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PRIMARY outcome
Timeframe: Perioperative (until discharge), an average of 6 days(\*NOTE: Device- or procedure-related AE refers only to the ATHERECTOMY PROCEDURE (with B-Laser™) and not the entire index procedure.) 1. Clinically Significant Perforations requiring intervention 2. Clinically Significant Dissections requiring intervention 3. Clinically Significant Embolus requiring intervention 4. Clinically Pseudo-aneurysm requiring intervention
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=50 Participants
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™.
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|---|---|
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Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1)
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50 Participants
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PRIMARY outcome
Timeframe: Intraoperative (during the index procedure, after B-Laser™ catheter crossing, before adjunctive therapy)Population: 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.
The technical success will be evaluated visually by the performing physician during procedure by fluoroscopy. It is evaluated per lesion and not per subject
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=52 lesions
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™.
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|---|---|
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Number of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire.
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52 lesions
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SECONDARY outcome
Timeframe: Perioperative (until discharge), an average of 6 days(\*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) 1. Emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator 2. Flow limiting dissection
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=50 Participants
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™.
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|---|---|
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Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2)
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50 Participants
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SECONDARY outcome
Timeframe: 30 days post procedure(\*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) 1. Clinically Significant Dissections requiring intervention 2. Clinically Significant Embolus requiring intervention 3. Clinically Pseudo-aneurysm requiring intervention
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=50 Participants
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™.
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|---|---|
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Number of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events
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50 Participants
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SECONDARY outcome
Timeframe: Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)Population: This endpoint is analyzed for lesions (53) and not for participants (50)
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
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=53 lesions
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™.
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|---|---|
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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
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38 lesions
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SECONDARY outcome
Timeframe: baseline and 30 days, 6 months and 12 months post procedurePopulation: The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points
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.
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=50 Participants
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™.
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|---|---|
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Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline
baseline
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0.57 ratio
Standard Deviation 0.14
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Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline
30 days
|
0.94 ratio
Standard Deviation 0.14
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Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline
6 months
|
0.84 ratio
Standard Deviation 0.20
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Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline
12 months
|
0.77 ratio
Standard Deviation 0.16
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SECONDARY outcome
Timeframe: baseline and 30 days, 6 months and 12 months post procedurePopulation: The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points
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.
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=50 Participants
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™.
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|---|---|
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Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
6 months · Rutherford class 3
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5 Participants
|
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Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
baseline · Rutherford class 0
|
0 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
baseline · Rutherford class 1
|
0 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
baseline · Rutherford class 2
|
10 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
baseline · Rutherford class 3
|
35 Participants
|
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Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
baseline · Rutherford class 4
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5 Participants
|
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Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
30 days · Rutherford class 0
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24 Participants
|
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Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
30 days · Rutherford class 1
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21 Participants
|
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Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
30 days · Rutherford class 2
|
3 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
30 days · Rutherford class 3
|
2 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
30 days · Rutherford class 4
|
0 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
6 months · Rutherford class 0
|
23 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
6 months · Rutherford class 1
|
12 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
6 months · Rutherford class 2
|
8 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
6 months · Rutherford class 4
|
0 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
12 months · Rutherford class 0
|
8 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
12 months · Rutherford class 1
|
11 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
12 months · Rutherford class 2
|
6 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
12 months · Rutherford class 3
|
4 Participants
|
|
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
12 months · Rutherford class 4
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline and 30 days, 6 months and 12 months post procedurePopulation: 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.
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.
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=49 Participants
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™.
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|---|---|
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Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline
baseline
|
34.16 score on a scale
Standard Deviation 8.15
|
|
Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline
30 days
|
71.72 score on a scale
Standard Deviation 19.88
|
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Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline
6 months
|
67.84 score on a scale
Standard Deviation 22.05
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Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline
12 months
|
53.30 score on a scale
Standard Deviation 18.09
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POST_HOC outcome
Timeframe: Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)Population: This endpoint is analyzed for lesions (53) and not for participants (50)
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
Outcome measures
| Measure |
B-Laser™ Atherectomy Catheter
n=53 lesions
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™.
|
|---|---|
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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
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48 lesions
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Adverse Events
B-Laser™ Atherectomy Catheter
Serious events: 14 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
B-Laser™ Atherectomy Catheter
n=46 participants at risk
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™.
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|---|---|
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Cardiac disorders
Angina Pectoris
|
2.2%
1/46 • Number of events 1 • 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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Cardiac disorders
Heart Failure
|
4.3%
2/46 • Number of events 2 • 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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Cardiac disorders
Chronic ischemic heart disease, unspecified
|
2.2%
1/46 • Number of events 1 • 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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Cardiac disorders
Non STEMI@Atrioventricular block@Cardiogenic shock@Acute renal failure
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Gastrointestinal disorders
Large intestine angiodysplasia
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage@ Esophagitis@ Gastroesophageal reflux disease
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Injury, poisoning and procedural complications
Vascular access site hematoma
|
4.3%
2/46 • Number of events 2 • 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'.
|
|
Vascular disorders
Superficial femoral arterial stenosis & Claudication@Leg ischemia@Disease progression
|
4.3%
2/46 • Number of events 2 • 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'.
|
|
Vascular disorders
Leg ischemia@Superficial femoral arterial stenosis@Claudication
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Cardiac disorders
Non STEMI@ Bradycardia
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Cardiac disorders
Angina pectoris unstable
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Vascular disorders
Leg ischemia@ Popliteal arterial restenosis
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.2%
1/46 • Number of events 1 • 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'.
|
Other adverse events
| Measure |
B-Laser™ Atherectomy Catheter
n=46 participants at risk
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™.
|
|---|---|
|
Vascular disorders
Vascular dissection
|
6.5%
3/46 • Number of events 3 • 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'.
|
|
Vascular disorders
Arterial occlusion
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Vascular disorders
Leg ischemia@Superficial femoral arterial stenosis
|
8.7%
4/46 • Number of events 4 • 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'.
|
|
Vascular disorders
Leg ischemia
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Vascular disorders
Claudication
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal bleeding
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
Infections and infestations
Skin infection
|
2.2%
1/46 • Number of events 1 • 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'.
|
|
General disorders
Edema lower limb
|
4.3%
2/46 • Number of events 2 • 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'.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place