Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

• Sponsor: Medtronic Endovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02363972
• Collaborator: (none)
• Enrollment: 103
• Locations: 5
• Arm: 1
• Actual Duration (Months): 15.7
• Patients Per Site: 20.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease; AV Fistula; Fistula; End Stage Kidney Disease	Device: Ellipsys Vascular Access Catheter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ellipsys Vascular Access Catheter System Clinical Trial
• Actual Study Start Date: Feb 10, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ellipsys Vascular Access Catheter ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula.	Device: Ellipsys Vascular Access Catheter; A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Outcome Measures

Primary Outcome Measures

1. Maturation Success Rate at 90 Days [90 days]

   Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.

2. Number of Participants With Device-related Serious Adverse Events [90 days]

   The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure.

Secondary Outcome Measures

1. Percent of Participants With Access Systems That Successfully Created an AVF [90 days]

   Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment

2. Percent of Access Sites With Clinical Patency at Discharge [90 days]

   Percent of access sites that demonstrated physical exam patency through clinic discharge

3. Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days [90 days]

   Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation

4. Percent of Access Sites That Achieved or Maintained Maturation at 90 Days [90 days]

   Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency.

5. Percent of Access Sites That Achieved Maturation Without Intervention [90 days]

   Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation

6. Percent of Access Sites That Were Patent Following Intervention [90 days]

   Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency

7. Percent of Access Sites That Achieved Patency Without Intervention [90 days]

   Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site

8. Intervention Rate [90 days]

   Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site

9. Transposition Rate [90 days]

   Percent of subjects who required one or more surgical transpositions performed to facilitate needle access

Other Outcome Measures

1. Time to First AVF Cannulation [90 days]

   Time to AVF cannulation was defined as the elapsed time to the first use of access site (from the date of the study procedure).

2. Catheter Utilization [90 days]

   Catheter utilization was defined as the total number of days a catheter was used before access site maturation per subject. The start date was either 1) the date of the study procedure, for subjects who already had a dialysis catheter in place or 2) the date placed, if during the study. The end date was either 1) the date the catheter was removed or 2) the 90 day visit, if the catheter was still in place.

3. Target Vessel Location [90 days]

   Anatomic location of matured target vessel

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients were eligible for enrollment into the study if they met the following criteria:

1. Patients ≥ 18 years of age and ≤ 80 years of age

2. Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)

3. Life expectancy of at least one year, per the investigator's opinion

4. Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment

5. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment

6. Adequate quality vein based on pre-operative assessment

7. Adjacent vein diameter of ≥ 2.0 mm at target anastomosis site

8. Confirmed clinically significant outflow

9. Adequate quality radial artery based on pre-operative assessment

1. Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site

1. Adequate collateral arterial perfusion

2. Patent palmar arch

3. Negative Allen's Test for ulnar artery insufficiency

4. No clinical evidence of subclavian artery stenosis on the ipsilateral side.

5. Radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure

6. Patient was able to provide written informed consent

7. Able to travel to enrolling institution for follow-up examinations

8. Able and willing to follow a daily aspirin and/or other anti-coagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant, see exclusion criteria 15)

Exclusion Criteria:

Patients were excluded if any of the following was true:

1. Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)

2. 1. Prior vascular surgery at or proximal (central) to the AVF target site b. Prior axillary dissection or mastectomy on the ipsilateral side as intended AV fistula site

3. History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment

4. Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side

5. Pre-existing vascular disease that could confound the study results

6. Systolic pressures < 100 mm Hg at the time of screening

7. Suspected or confirmed skin disease at the skin entry site

8. Immunocompromised patients (e.g. HIV positive)

9. Edema of the upper extremity on the ipsilateral side

10. Patients requiring immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day

11. Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3

12. Current diagnosis of carcinoma (defined as in remission < 1 year)

13. Pregnant or currently breast feeding

14. Known bleeding diathesis or coagulation disorder

15. Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy

16. Patients with acute or active infection

17. Scheduled kidney transplant within 6 months of enrollment

18. Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)

19. History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment

20. Patient required creation of an arteriovenous fistula distal to the wrist

21. Patient required nerve block requiring immobilization of the arm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Vascular Center	Tempe	Arizona	United States	85281
2	BNMG San Diego Vascular Access Center	San Diego	California	United States	92115
3	Dallas Nephrology Associates	Plano	Texas	United States	75093
4	San Antonio Kidney Disease Center	San Antonio	Texas	United States	78016
5	Richmond Vascular Center	North Chesterfield	Virginia	United States	23236

Sponsors and Collaborators

• Medtronic Endovascular

Investigators

• Principal Investigator: Jeffrey Hull, MD, Richmond Vascular Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Endovascular
• ClinicalTrials.gov Identifier: NCT02363972
• Other Study ID Numbers: 01-0014-01
• First Posted: Feb 16, 2015
• Last Update Posted: Nov 9, 2021
• Last Verified: Nov 1, 2021

• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Arteriovenous Fistula; Fistula

Study Results

Participant Flow

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Period Title: Overall Study
STARTED	103
COMPLETED	77
NOT COMPLETED	26

Baseline Characteristics

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Overall Participants	103
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.6 (12)
Sex: Female, Male (Count of Participants)
Female	27 26.2%
Male	76 73.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	37 35.9%
Not Hispanic or Latino	65 63.1%
Unknown or Not Reported	1 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 1.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	21 20.4%
White	77 74.8%
More than one race	0 0%
Unknown or Not Reported	3 2.9%

Outcome Measures

1. Primary Outcome

Title	Maturation Success Rate at 90 Days
Description	Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	103
Count of Participants [Participants]	92 89.3%

2. Primary Outcome

Title	Number of Participants With Device-related Serious Adverse Events
Description	The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	103
Count of Participants [Participants]	0 0%

3. Secondary Outcome

Title	Percent of Participants With Access Systems That Successfully Created an AVF
Description	Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	103
Count of Participants [Participants]	102 99%

4. Secondary Outcome

Title	Percent of Access Sites With Clinical Patency at Discharge
Description	Percent of access sites that demonstrated physical exam patency through clinic discharge
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	102
Count of Participants [Participants]	98 95.1%

5. Secondary Outcome

Title	Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days
Description	Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (65) is a subset of of the overall number of participants analyzed (103) due to not all participants being on dialysis an requiring 2 needle cannulation by the 90 day outcome measure time frame

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	65
Count of Participants [Participants]	29 28.2%

6. Secondary Outcome

Title	Percent of Access Sites That Achieved or Maintained Maturation at 90 Days
Description	Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	102
Count of Participants [Participants]	85 82.5%

7. Secondary Outcome

Title	Percent of Access Sites That Achieved Maturation Without Intervention
Description	Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	102
Count of Participants [Participants]	1 1%

8. Secondary Outcome

Title	Percent of Access Sites That Were Patent Following Intervention
Description	Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	102
Count of Participants [Participants]	89 86.4%

9. Secondary Outcome

Title	Percent of Access Sites That Achieved Patency Without Intervention
Description	Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	102
Count of Participants [Participants]	1 1%

10. Secondary Outcome

Title	Intervention Rate
Description	Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	102
Count of Participants [Participants]	98 95.1%

11. Secondary Outcome

Title	Transposition Rate
Description	Percent of subjects who required one or more surgical transpositions performed to facilitate needle access
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	102
Count of Participants [Participants]	19 18.4%

12. Other Pre-specified Outcome

Title	Time to First AVF Cannulation
Description	Time to AVF cannulation was defined as the elapsed time to the first use of access site (from the date of the study procedure).
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (33) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not requiring cannulation by the 90 day outcome timeframe

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	33
Mean (Standard Deviation) [Days]	67.8 (15.9)

13. Other Pre-specified Outcome

Title	Catheter Utilization
Description	Catheter utilization was defined as the total number of days a catheter was used before access site maturation per subject. The start date was either 1) the date of the study procedure, for subjects who already had a dialysis catheter in place or 2) the date placed, if during the study. The end date was either 1) the date the catheter was removed or 2) the 90 day visit, if the catheter was still in place.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (32) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not requiring a catheter utilization by the 90 day outcome timeframe

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	32
Mean (Standard Deviation) [days]	83.1 (17.4)

14. Other Pre-specified Outcome

Title	Target Vessel Location
Description	Anatomic location of matured target vessel
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

The analysis population analyzed (90) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not achieving an identifiable target vein by the 90 day outcome timeframe

Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Measure Participants	90
Cephalic vein	68 66%
Basilic vein	20 19.4%
Brachial vein 1	1 1%
Brachial vein 2	1 1%

Adverse Events

Time Frame	90 days
Adverse Event Reporting Description	Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Arm/Group Title	Ellipsys Vascular Access Catheter
Arm/Group Description	ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
All Cause Mortality
	Ellipsys Vascular Access Catheter
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ellipsys Vascular Access Catheter
	Affected / at Risk (%)	# Events
Total	18/103 (17.5%)
Cardiac disorders
Cardiac serious adverse events	4/103 (3.9%)
Endocrine disorders
Endocrine, metabolic nutritional serious adverse events	1/103 (1%)
Gastrointestinal disorders
Gastrointestinal serious adverse events	2/103 (1.9%)
Musculoskeletal and connective tissue disorders
Musculoskeletal serious adverse events	2/103 (1.9%)
Nervous system disorders
Nervous system serious adverse events	1/103 (1%)
Respiratory, thoracic and mediastinal disorders
Respiratory serious adverse events	2/103 (1.9%)
Skin and subcutaneous tissue disorders
Skin and subcutaneous serious adverse events	1/103 (1%)
Social circumstances
Uncoded	1/103 (1%)
Vascular disorders
Vascular, blood and lymphatic serious adverse events	4/103 (3.9%)
Other (Not Including Serious) Adverse Events
	Ellipsys Vascular Access Catheter
	Affected / at Risk (%)	# Events
Total	28/103 (27.2%)
Ear and labyrinth disorders
Eye, ear nonserious events	1/103 (1%)
Immune system disorders
Immune, infection nonserious events	3/103 (2.9%)
Investigations
Drug effect nonserious adverse events	1/103 (1%)
Musculoskeletal and connective tissue disorders
musculoskeletal nonserious adverse events	3/103 (2.9%)
Skin and subcutaneous tissue disorders
Skin nonserious adverse events	2/103 (1.9%)
Surgical and medical procedures
Surgical procedure nonserious adverse events	1/103 (1%)
Vascular disorders
Vascular, blood nonserious adverse events	17/103 (16.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.