NCT04633304

A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population (STEP Study)

A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: California Institute of Renal Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated post-marketing study that will evaluate use of the WaveLinQ system, a new and novel method of fistula creation using a percutaneous method in patients who require the creation of an arteriovenous fistula (AVF).

Detailed description

This investigator-initiated post-marketing study will evaluate use of the WaveLinQ system, a new and novel method of fistula creation, which uses a percutaneous method to create an AVF. Thirty male and female subjects with CKD 3-5 and who are clinical indicated for arteriovenous fistula (AVF) creation will be enrolled using the WaveLinQ device. Eligibility confirmation will be confirmed during screening up to 28 days from the index procedure. Subjects who are eligible will undergo fistula creation per standard institutional technique (index/baseline) and be followed at least monthly for 6 months per their standard of care plan. Primary, clinical and functional patency will be observed throughout the trial in addition to other data collection points per protocol. The expected total duration of subject participation from screening until the end of study is up to 7 months.

Conditions

• CKD Stage 3
• CKD Stage 4
• CKD Stage 5

Interventions

Type	Name	Description
DEVICE	EndoAVF System for endovascular AV fistula creation	AV fistula creation

Timeline

• Start date: 2020-12-15
• Primary completion: 2023-12-15
• Completion: 2023-12-31
• First posted: 2020-11-18
• Last updated: 2023-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study