An interventional study of Percutaneous creation of an arteriovenous fistula in Renal Insufficiency, Chronic, sponsored by Medtronic Endovascular. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by Medtronic Endovascular · Not applicable, Interventional, and Treatment
Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 26 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Medtronic Endovascular is the lead sponsor of 50 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula
Device: Percutaneous creation of an arteriovenous fistula
Use of catheter system for percutaneous creation of an arteriovenous fistula
Number of Participants With Sufficient Patency for Clinical Access
Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.
Time frame: 6 weeks
Number of Patients Achieving Dialysis Access
Arteriovenous fistula is mature and patient has started dialysis using the fistula
Time frame: 6 weeks
Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis
Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis
Time frame: 3 months
Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access
The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.
Time frame: 12 weeks
| Milestone | Treatment |
|---|---|
| Started | 26 |
| Completed | 12 |
| Not completed | 14 |
| Withdrew: Death | 5 |
| Withdrew: Lack of efficacy | 8 |
| Withdrew: Lost to follow-up | 1 |
Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.
| Participants | Treatment |
|---|---|
| Number of Participants With Sufficient Patency for Clinical Access | 20 |
Arteriovenous fistula is mature and patient has started dialysis using the fistula
| Participants | Treatment |
|---|---|
| Number of Patients Achieving Dialysis Access | 1 |
Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis
| Participants | Treatment |
|---|---|
| Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis | 20 |
The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.
| Participants | Treatment |
|---|---|
| Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access | 23 |
Collected over Adverse event data was collected over a period of 6 months from index procedure through arteriovenous fistula maturation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | — | 9/23 (39.1%) | 0/23 (0%) |
| Event | Treatment |
|---|---|
| DeathGeneral disorders | 5/23 |
| Acute thrombosisVascular disorders | 3/23 |
| HematomaBlood and lymphatic system disorders | 1/23 |
| Age, Categorical(Participants) | Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 24 |
| >=65 years | 2 |
| Age, Continuous(Years) | Treatment |
|---|---|
| Mean | 45.5 ± 13.6 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 16 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 26 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| Mexico | 26 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Medtronic Endovascular