Trial Outcomes & Findings for The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation (NCT NCT04626427)
NCT ID: NCT04626427
Last Updated: 2025-01-16
Results Overview
Clinical Investigation Plan (CIP) Endpoint Definition: The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs. The CEC established criteria to determine the relatability of an adverse event (AE) to the device and/or the index procedure. Based on these criteria, AEs were adjudicated to be "definitely related", "possibly related", or "not related". Events adjudicated to be "definitely" or "possibly" related were considered to be related events. NOTE: Due to early termination of the investigation, this endpoint is presented as the number of participants with freedom from CEC adjudicated device- or procedure-related SAEs.
TERMINATED
NA
21 participants
30 days
2025-01-16
Participant Flow
21 participants signed informed consent prior to investigation early termination.
21 participants had signed informed consent. 14 were treated with the device. Six (6) were screen failures: Four (4) did not meet anatomical eligibility and two (2) did not meet clinical eligibility criteria. One (1) participant did not have the device inserted. This participant had signed consent prior to investigation termination but the procedure was completed after the investigation had terminated as part of standard of care.
Participant milestones
| Measure |
WavelinQ™ EndoAVF System
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an arteriovenous fistula (AVF) used for hemodialysis (HD). The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its instructions for use (IFU).
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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Overall Study
STARTED
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14
|
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Overall Study
30-Day Follow-Up
|
13
|
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Overall Study
6-Week Follow-Up
|
12
|
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Overall Study
3-Month Follow-Up
|
12
|
|
Overall Study
6-Month Follow-Up
|
11
|
|
Overall Study
12-Month Follow-Up
|
2
|
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Overall Study
COMPLETED
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0
|
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Overall Study
NOT COMPLETED
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14
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Reasons for withdrawal
| Measure |
WavelinQ™ EndoAVF System
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an arteriovenous fistula (AVF) used for hemodialysis (HD). The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its instructions for use (IFU).
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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Overall Study
Death
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1
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Investigation Early Termination by Sponsor
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11
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Overall Study
Participant Permanently Moved Abroad
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1
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Baseline Characteristics
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
Baseline characteristics by cohort
| Measure |
WavelinQ™ EndoAVF System
n=14 Participants
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an arteriovenous fistula (AVF) used for hemodialysis (HD). The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its instructions for use (IFU).
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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Age, Continuous
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60.9 years
STANDARD_DEVIATION 16.52 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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13 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Greece
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5 participants
n=5 Participants
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Region of Enrollment
Belgium
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5 participants
n=5 Participants
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Region of Enrollment
Switzerland
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4 participants
n=5 Participants
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Body Mass Index (BMI)
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24.91 kg/m^2
STANDARD_DEVIATION 4.536 • n=5 Participants
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PRIMARY outcome
Timeframe: 30 daysClinical Investigation Plan (CIP) Endpoint Definition: The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs. The CEC established criteria to determine the relatability of an adverse event (AE) to the device and/or the index procedure. Based on these criteria, AEs were adjudicated to be "definitely related", "possibly related", or "not related". Events adjudicated to be "definitely" or "possibly" related were considered to be related events. NOTE: Due to early termination of the investigation, this endpoint is presented as the number of participants with freedom from CEC adjudicated device- or procedure-related SAEs.
Outcome measures
| Measure |
WavelinQ™ EndoAVF System
n=13 Participants
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its IFU.
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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Safety: Device and Procedure Related Serious Adverse Events (SAEs) - Presented as the Number of Participants With Freedom From Clinical Events Committee (CEC) Adjudicated Device and/or Procedure-Related SAEs.
Overall Number of Participants with Freedom from CEC Adjudicated Device &/ Procedure Related SAEs
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12 Participants
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Safety: Device and Procedure Related Serious Adverse Events (SAEs) - Presented as the Number of Participants With Freedom From Clinical Events Committee (CEC) Adjudicated Device and/or Procedure-Related SAEs.
Possible Procedure-Related SAE (Azotaemia - 7 days Post-Index Procedure with 4 Day Hospitalization)
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1 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: To provide details on the calculation on the rate given the early termination of the investigation - the mean (standard deviation) number of interventions used was 0.5 (0.76) and the mean (standard deviation) number of patient years used was 0.5 (0.20). This provided the rate presented in the Outcome Measure Data Table.
CIP Endpoint Definition: The number of interventions per patient years to facilitate and / or maintain AVF use (facilitation interventions and / or maintenance interventions). The assessment of interventions to facilitate and/or maintain AVF use started post creation (after the completion of the index procedure). NOTE: For the calculation of the endpoint, the number of Interventions per Patient Years to Facilitate and / or Maintain AVF Use was to be estimated by using the Poisson regression model. Given the early termination of the investigation the mean and standard deviation of the Number of Interventions and Patient Years used for the derivation are provided in the Analysis Population Description.
Outcome measures
| Measure |
WavelinQ™ EndoAVF System
n=14 Participants
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its IFU.
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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Effectiveness: Number of Interventions Per Patient Years to Facilitate and / or Maintain AVF Use
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1.00 Number of Interventions / Patient Years
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SECONDARY outcome
Timeframe: 6 months (24 months was also to be reported per the CIP but due to investigation early termination only data through 6 months was able to be evaluated).CIP Endpoint Definition: The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs. The CEC established criteria to determine the relatability of an adverse event (AE) to the device and/or the index procedure. Based on these criteria, AEs were adjudicated to be "definitely related", "possibly related", or "not related". Events adjudicated to be "definitely" or "possibly" related were considered to be related events. NOTE: Due to early termination of the investigation, this endpoint is presented as the number of participants with freedom from CEC adjudicated device- or procedure-related SAEs. This included the assessment of the 12 participants that reached 6-months prior to investigation early termination. No further related SAEs were identified in this time period from the one part of the primary safety endpoint.
Outcome measures
| Measure |
WavelinQ™ EndoAVF System
n=12 Participants
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its IFU.
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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|---|---|
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Device and Procedure Related SAEs - Presented as the Number of Participants With Freedom From CEC Adjudicated Device and/or Procedure-Related SAEs.
Overall Number of Participants with Freedom from CEC Adjudicated Device &/ Procedure Related SAEs
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11 Participants
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Device and Procedure Related SAEs - Presented as the Number of Participants With Freedom From CEC Adjudicated Device and/or Procedure-Related SAEs.
Possible Procedure-Related SAE (Azotaemia - 7 days Post-Index Procedure with 4 Day Hospitalization)
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1 Participants
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SECONDARY outcome
Timeframe: 6 weeksCIP Endpoint Definition: The proportion of participants with AVFs that meet the CIP definition of physiological maturation as measured by DUS. Core Lab data was the primary source for endpoint derivation. In the event where core lab data was unavailable, site reported data was used. Physiological maturation was defined as an AVF having at least 500 mL/min of flow in the brachial artery and an outflow vein diameter of ≥4 mm as measured by DUS. Participants with AVFs that met the definition of functional maturation were automatically considered to have met the endpoint of physiological maturation. NOTE: Due to the early termination of the investigation this endpoint is presented as the number of participants with AVFs that meet the definition of physiological maturation as measured by DUS.
Outcome measures
| Measure |
WavelinQ™ EndoAVF System
n=13 Participants
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its IFU.
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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Physiological Maturation - Presented as the Number of Participants With AVFs That Meet the CIP Definition of Physiological Maturation as Measured by Duplex Ultrasound (DUS).
Missing DUS / HD Data - Unable to Confirm Physiological Maturation (CIP Deviation)
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1 Participants
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Physiological Maturation - Presented as the Number of Participants With AVFs That Meet the CIP Definition of Physiological Maturation as Measured by Duplex Ultrasound (DUS).
Overall Number of Participants with Physiological Maturation
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12 Participants
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SECONDARY outcome
Timeframe: 6 monthsPopulation: NOTE: The overall assessment of the fourteen (14) participants includes three (3) incident (pre-HD) participants that never required HD during the investigation. The % of the eleven (11) subjects that were eligible for HD during the course of the investigation that achieved cannulation success prior to investigation early termination is also provided in the outcome table.
CIP Endpoint Definition: The interval of time between HD arteriovenous (AV) access creation to first successful use for HD and proportion of participants with successful first use for HD as defined in the CIP. Cannulation Success is defined as the first successful use for HD using 2-needle cannulation. NOTE: Given the early termination of the investigation, this endpoint is presented as the percentage of participants with successful first use for HD. The Kaplan-Meier (KM) method was used to estimate the proportion of participants with success at 6 months.
Outcome measures
| Measure |
WavelinQ™ EndoAVF System
n=14 Participants
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its IFU.
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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Cannulation Success - Presented as the Percentage of Participants With Cannulation Success.
Percentage of All Participants with Success - KM (%)
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46.2 % of Participants with Success
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Cannulation Success - Presented as the Percentage of Participants With Cannulation Success.
Percentage of HD Eligible Participants with Cannulation Success (%)
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72.7 % of Participants with Success
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SECONDARY outcome
Timeframe: Through Investigation Early TerminationPopulation: NOTE: The overall assessment of the fourteen (14) participants includes three (3) incident (pre-HD) participants that never required HD during the investigation.
CIP Endpoint Definition: The interval of time between HD arteriovenous (AV) access creation to first successful use for HD and proportion of participants with successful first use for HD as defined in the CIP. Cannulation Success is defined as the first successful use for HD using 2-needle cannulation. The median time to success was to be estimated using the Kaplan Meier curve and defined as the time at which 50% of participants reached success by the end of the 6-month window. By the end of the 6-month window, the estimated success rate was 46.2% (see Secondary Outcome above "Cannulation Success - Percentage of Participants With Cannulation Success") as such, there weren't sufficient data points with successes to get this estimate. Instead the minimum and maximum number of days to cannulation success for all participants through investigation early termination is provided.
Outcome measures
| Measure |
WavelinQ™ EndoAVF System
n=14 Participants
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its IFU.
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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|---|---|
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Cannulation Success - Presented as the Number of Days to Cannulation Success.
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NA Time to Success (Days)
Interval 32.0 to 210.0
Given the definition of the median time to success (see "Outcome Measure Description") and the limited sample size due to early termination this estimate could not be determined.
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SECONDARY outcome
Timeframe: 6 months (12 months per CIP but due to investigation early termination data is reported through 6 months instead due to the limited resultant data available at 12 months)Population: For the five (5) participants that had sufficient follow-up time prior to investigation termination, the cumulative functional patency through 6-months was evaluated.
CIP Endpoint Definition: The time from first successful HD AV access use for HD using 2-needle cannulation to access abandonment, when the access reaches an access censoring event as specified a priori in the CIP, or analysis timepoint / clinical investigation end. NOTE: Given the early termination of the investigation the endpoint is presented as the number of participants that had met the definition of cumulative functional patency - those that (1) had initiated HD successfully through their AVF with 2-needle cannulation and (2) whose AVF was not abandoned.
Outcome measures
| Measure |
WavelinQ™ EndoAVF System
n=5 Participants
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its IFU.
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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Cumulative Functional Patency - Presented as the Number of Participants With Cumulative Functional Patency
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5 Participants
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Adverse Events
WavelinQ™ EndoAVF System
Serious adverse events
| Measure |
WavelinQ™ EndoAVF System
n=14 participants at risk
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its IFU.
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
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7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
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Injury, poisoning and procedural complications
Arteriovenous Fistula Site Pseudoaneurysm
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7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
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Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
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7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
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7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
|
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Renal and urinary disorders
Azotaemia
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7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
|
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Infections and infestations
Staphylococcal Sepsis
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7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
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Vascular disorders
Brachiocephalic Vein Stenosis
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7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
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Other adverse events
| Measure |
WavelinQ™ EndoAVF System
n=14 participants at risk
The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System was used for these intended purposes as part of this clinical investigation according to its IFU.
WavelinQ™ EndoAVF System: AVF endovascular creations using the WavelinQ™ EndoAVF System
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|---|---|
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General disorders
Puncture Site Haematoma
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7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
|
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Infections and infestations
Covid-19
|
7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
|
|
Injury, poisoning and procedural complications
Limb Fracture
|
7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
|
|
General disorders
Catheter Site Haemorrhage
|
7.1%
1/14 • Number of events 1 • Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).
ISO14155:2020 definitions were used for adverse events (AEs) and serious adverse events (SAEs). Note: Planned hospital visits and / or hospital stays, or procedures required by the CIP (including subsequent interventions assessed in the clinical investigation endpoints), without serious deterioration in health were not to be considered SAEs.
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Additional Information
Simon Lubek, Clinical Program Manager
Becton Dickinson
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place