Ark Cannulation Trial II

Vascular Access Complication Clinical Trial

— ACT II  

Official title:

A Study to Evaluate the Safety and Effectiveness of the Voyager Ark for Patients Undergoing Routine Hemodialysis (Ark Cannulation Trial II)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05490225
• Other study ID #: Ark Cannulation Trial II
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: November 1, 2028

Study information

• Verified date: April 2024
• Source: BioTex, Inc.
• Contact: Britnee L Ochabski
• Phone: 713-741-0111
• Email: britnee.ochabski[@]biotexmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the Ark based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.

Description:

This clinical investigation is estimated to last approximately 48-60 months, from initial participant enrollment until all data collection is complete on the final participant. After the patient has the Ark device implanted, they will be observed for 6 weeks as the implant site heals. The patient will be monitored for 36 months after device implantation as they undergo routine dialysis. Subjects will exit the investigation after the last visit and no device-related adverse events have been identified or are being monitored

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 1, 2028
• Est. primary completion date: November 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

AVF is uncannulatable* in upper arm or forearm per the attending nephrologist and independent cannulation specialist, and has been referred for vascular access.

1. *AVF is deemed 'uncannulatable' if at least one of the following apply:

• Three or more failed access attempts within a 2-week time period.

• The fistula cannot be palpated to locate and define its margins.

• The fistula is only cannulatable in a segment that is too short to appropriately accommodate two needles.

• Vessel is too tortuous to be cannulated adequately to accommodate needle.

• The fistula is only cannulatable (i.e. <6mm deep) in a segment that is too short (i.e. < 5cm) to allow adequate separation of arterial and venous cannulas without recirculation. Even though it should be cannulatable, the segment is too short.

• Aneurysm is in the only area for access because the rest of the fistula is not accessible.

2. The subject's depth of the anterior surface of the access vein at each planned implantation site is between 4-15mm as measured by ultrasound within 8 weeks prior to Ark implantation.

3. The subject's fistula diameter at each planned implantation site is =5mm as measured by ultrasound within 8 weeks prior to Ark implantation.

4. The subject does not have clinically significant flow abnormalities and they have an AVF flow =500 mL/min as measured by ultrasound within 8 weeks prior to Ark implantation.

5. The subject has either a radio-cephalic, brachio-cephalic or transposed brachio-basilic fistula.

6. The subject has a prescription to receive maintenance hemodialysis at least 2 times per week.

7. The subject's planned cannulation technique is either rope-ladder or buttonhole.

8. The subject's life expectancy is =1 year per the Investigator.

9. The subject must have signed and dated the 753-016-2001 Informed Consent Form.

Exclusion:

1. The AVF is a non-transposed basilic or brachial vein outflow AVF.

2. The subject has high flow rates placing them at risk for heart failure and death at the discretion of the Investigator.

3. The subject has a known skin infection, hypersensitive skin, skin breakdown/erosion or skin allergies at the potential implant sites.

4. The subject has a known active systemic infection or positive blood cultures present.

5. The subject's AVF has undergone a major revision and at the discretion of the Investigator can impact fistula viability and Ark placement (such as DRIL or PTFE segment insertion, banding, aneurysm repair, etc.), or the subject has had an occurrence of and/or intervention for AV access stenosis or thrombosis within the past month (excluded to avoid unnecessary placement into an AVF with high likelihood of failure).

6. The subject is <18 years of age.

7. The subject plans to become pregnant prior to their potential treatment date.

8. The subject has a body mass index >50kg/m2.

9. The subject has a known clinically significant bleeding or coagulation disorder, including but not limited to low platelet count (<50,000), hypercoagulable state (e.g., antithrombin IE deficiency, antiphospholipid or anticardiolipin antibodies, Factor V Leiden, circulating Lupus anticoagulant, current, heparin-induced thrombocytopenia, protein C or S deficiency, history of recurrent deep vein thrombosis not related to AV access).

10. The subject has an active malignancy.

11. The subject has a known or suspected allergy to titanium, aluminum, or vanadium.

12. The subject has had a significant cardiovascular event/intervention that makes them a poor surgical candidate such as myocardial infarction, angioplasty, or stent placement within 3 months of implantation.

13. The subject has had a significant peripheral vascular disease requiring a major intervention within the previous 12 months.

14. The subject has had a significant neurovascular event such as stroke or major intervention within the previous 12 months.

15. The subject has an uncontrolled major symptomatic medical problem per the Investigator.

16. The subject has a likelihood of poor protocol compliance due to mental incapacity, an inability to understand treatment instructions, or for any other reason in the opinion of the Investigator.

17. The subject is currently participating in another investigational drug or device investigation that could clinically interfere with the endpoints of this investigation.

18. The subject's conversion to home hemodialysis is anticipated at any point during their foreseeable participation this investigation.

19. The subject has long dialysis vintage, is elderly, has diabetic nephropathy, severe atherosclerosis and/or extensive vascular calcification, and in the opinion of the Investigator should be excluded due to concern of the integrity of the implant and its attachment to the blood vessel wall in the subject.

Related Conditions & MeSH terms

• Dialysis; Complications
• Vascular Access Complication

Intervention

Device:
• Ark Implantation
The Ark is a two-piece, porous, 3D-printed, titanium device that surrounds a segment of the access vein arising from an arterio-venous fistula. The top of the Ark has an opening designed for easy needle insertion using a standard dialysis needle. These novel features of the Ark venous access port are designed to: Create a palpable target for easier cannulation of the access vein; Provide protection of the side and back walls of the access vein from unintended puncture; Reinforce the access vein by acting as an external support; Provide a porous structure designed to integrate with surrounding tissues and reduce the chance of foreign body reaction for long-term use.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioTex, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome 1	Primary, Primary Assisted, Secondary, and Functional Patency utilizing Kaplan-Meier methodology.	6 weeks, 3 months, 6 months, 12 months
Other	Exploratory Outcome 2	Infiltration rate and AVF failure rate after infiltration	6 weeks, 3 months, 6 months, 12 months
Other	Exploratory Outcome 3	Patient Satisfaction Survey	Screening/Baseline, 6 weeks, 3 months, 6 months, 12 months
Primary	To demonstrate the effectiveness of the Ark in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.	To demonstrate a 75% success rate in achieving successful access for hemodialysis when attempting cannulation through the Ark within a single 4-week period over a 6-month timeframe from approved cannulation, in at least 75% of evaluable subjects.	6 months
Primary	To evaluate the safety of the Ark.	The assessment and occurrence of device-related, serious adverse events (SAEs) of clinical interest (infection, aneurysm, seroma) during a 12-month follow-up period from initial implantation adjudicated by an independent reviewer.	12 months
Secondary	To investigate time-related parameters surrounding the Ark in facilitating hemodialysis.	Cumulative number of days between Ark implantation and Catheter removal. Days to successful cannulation and hemodialysis through the Ark.	24 months