CKD Stage 3NCT04633304
A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population (STEP Study)
A study testing EndoAVF System for endovascular AV fistula creation in people with CKD Stage 3 and CKD Stage 4, run by California Institute of Renal Research at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD Stage 3, CKD Stage 4, CKD Stage 5
- What is being tested?
- EndoAVF System for endovascular AV fistula creation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female Age of at least 18 years
- CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart.
- Provide written informed consent using a form that is approved by the Institutional Review Board (IRB) prior to collection of study data or performance of study procedures.
- Currently not on hemodialysis.
- Life expectancy of at least one year
- Meets Anatomical Criteria for EndoAVF creation via pre-procedure Duplex or Venography Vascular anatomy suitable for creation of the AV fistula
- Willing to comply with the specified follow-up evaluations
Who cannot join
- Anatomical exclusion criteria met
- Thought to need dialysis within 30 days.
- The subject is in a hypercoagulable state.
- The subject has known bleeding diathesis.
- The subject has insufficient cardiac output to support a native fistula in the opinion of the investigator.
- Known history of active intravenous drug abuse.
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- The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
- The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
- Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Institute of Renal Research
Escondido, California, 92027
Osman Khawar, MD, 760-294-3162, okhawar@bnmg.org
Claudia Ulloa, 7602943162, culloa@balboaunited.org
About this study
Official title: A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population
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).
Read the 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
- Being tested
- EndoAVF System for endovascular AV fistula creation
- Keywords
- CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoAVF System for endovascular AV fistula creationDevice
Also called WavelinQ™
AV fistula creation
| Study group | Role | What they receive |
|---|---|---|
| AVF | Other | Single arm study using primary and secondary end points as comperators between subjects. Receives: Device: EndoAVF System for endovascular AV fistula creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Success
Successful endoAVF creation confirmed by intraprocedural angiography or duplex Ultrasound post procedure
Measured: Interval of time from access placement until any intervention is undertaken to maintain or re-establish patency - 6 weeks
Secondary outcomes (1)
Physiologically mature endoAVF at 6 months
Percent of patients who did not require any intervention to be undertaken to maintain or re-establish patency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start15 Dec 2020
- Primary completion15 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CKD Stage 3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- primary end point
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Institute of Renal Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osman Khawar, MD, Principal investigator, California Institute of Renal Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633304
- Sponsor's protocol ID
- STP-001
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jones RG, Khawaja A, Tullett K, Inston NG. Early experience and observations in endovascular dialysis fistula re-intervention. J Vasc Access. 2020 Nov;21(6):818-825. doi: 10.1177/1129729819888374. Epub 2019 Dec 9.
PubMed 31814515Inston N, Khawaja A, Tullett K, Jones R. WavelinQ created arteriovenous fistulas versus surgical radiocephalic arteriovenous fistulas? A single-centre observational study. J Vasc Access. 2020 Sep;21(5):646-651. doi: 10.1177/1129729819897168. Epub 2020 Jan 2.
PubMed 31894716Lok CE, Rajan DK, Clement J, Kiaii M, Sidhu R, Thomson K, Buldo G, Dipchand C, Moist L, Sasal J; NEAT Investigators. Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the Prospective, Multicenter Novel Endovascular Access Trial (NEAT). Am J Kidney Dis. 2017 Oct;70(4):486-497. doi: 10.1053/j.ajkd.2017.03.026. Epub 2017 Jun 14.
PubMed 28624422Radosa CG, Radosa JC, Weiss N, Schmidt C, Werth S, Hofmockel T, Plodeck V, Gatzweiler C, Laniado M, Hoffmann RT. Endovascular Creation of an Arteriovenous Fistula (endoAVF) for Hemodialysis Access: First Results. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1545-1551. doi: 10.1007/s00270-017-1750-x. Epub 2017 Aug 7.
PubMed 28785804Berland TL, Clement J, Griffin J, Westin GG, Ebner A. Endovascular Creation of Arteriovenous Fistulae for Hemodialysis Access with a 4 Fr Device: Clinical Experience from the EASE Study. Ann Vasc Surg. 2019 Oct;60:182-192. doi: 10.1016/j.avsg.2019.02.023. Epub 2019 May 8.
PubMed 31075457Zemela MS, Minami HR, Alvarez AC, Smeds MR. Real-World Usage of the WavelinQ EndoAVF System. Ann Vasc Surg. 2021 Jan;70:116-122. doi: 10.1016/j.avsg.2020.05.006. Epub 2020 May 15.
PubMed 32417285
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population
- ClinicalTrials.gov ID
- NCT04633304
- Acronym / sponsor ID
- STP-001
- Conditions
- CKD Stage 3, CKD Stage 4, CKD Stage 5
- Keywords
- CKD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- California Institute of Renal ResearchUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- primary end point
| Arm | Type | Receives |
|---|---|---|
| AVF | Other | Device: EndoAVF System for endovascular AV fistula creationSingle arm study using primary and secondary end points as comperators between subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female Age of at least 18 years
- CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart.
- Provide written informed consent using a form that is approved by the Institutional Review Board (IRB) prior to collection of study data or performance of study procedures.
- Currently not on hemodialysis.
- Life expectancy of at least one year
Key exclusion criteria (9 listed)
- Anatomical exclusion criteria met
- Thought to need dialysis within 30 days.
- The subject is in a hypercoagulable state.
- The subject has known bleeding diathesis.
- The subject has insufficient cardiac output to support a native fistula in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoAVF System for endovascular AV fistula creationAlso: WavelinQ™AV fistula creation | Device | AVF |
Primary outcome
Procedure Success
Time frame: Interval of time from access placement until any intervention is undertaken to maintain or re-establish patency - 6 weeks
Successful endoAVF creation confirmed by intraprocedural angiography or duplex Ultrasound post procedure
1 secondary outcome
Physiologically mature endoAVF at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 31814515Jones RG, Khawaja A, Tullett K, Inston NG. Early experience and observations in endovascular dialysis fistula re-intervention. J Vasc Access. 2020 Nov;21(6):818-825. doi: 10.1177/1129729819888374. Epub 2019 Dec 9.
- Background: PubMed 31894716Inston N, Khawaja A, Tullett K, Jones R. WavelinQ created arteriovenous fistulas versus surgical radiocephalic arteriovenous fistulas? A single-centre observational study. J Vasc Access. 2020 Sep;21(5):646-651. doi: 10.1177/1129729819897168. Epub 2020 Jan 2.
- Results publication: PubMed 28624422Lok CE, Rajan DK, Clement J, Kiaii M, Sidhu R, Thomson K, Buldo G, Dipchand C, Moist L, Sasal J; NEAT Investigators. Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the Prospective, Multicenter Novel Endovascular Access Trial (NEAT). Am J Kidney Dis. 2017 Oct;70(4):486-497. doi: 10.1053/j.ajkd.2017.03.026. Epub 2017 Jun 14.
- Results publication: PubMed 28785804Radosa CG, Radosa JC, Weiss N, Schmidt C, Werth S, Hofmockel T, Plodeck V, Gatzweiler C, Laniado M, Hoffmann RT. Endovascular Creation of an Arteriovenous Fistula (endoAVF) for Hemodialysis Access: First Results. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1545-1551. doi: 10.1007/s00270-017-1750-x. Epub 2017 Aug 7.
- Results publication: PubMed 31075457Berland TL, Clement J, Griffin J, Westin GG, Ebner A. Endovascular Creation of Arteriovenous Fistulae for Hemodialysis Access with a 4 Fr Device: Clinical Experience from the EASE Study. Ann Vasc Surg. 2019 Oct;60:182-192. doi: 10.1016/j.avsg.2019.02.023. Epub 2019 May 8.
- Results publication: PubMed 32417285Zemela MS, Minami HR, Alvarez AC, Smeds MR. Real-World Usage of the WavelinQ EndoAVF System. Ann Vasc Surg. 2021 Jan;70:116-122. doi: 10.1016/j.avsg.2020.05.006. Epub 2020 May 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osman Khawar, MD principal investigator
California Institute of Renal Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoAVF System for endovascular AV fistula creation in people with CKD Stage 3 and CKD Stage 4, run by California Institute of Renal Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osman Khawar, MD (7602943162, okhawar@bnmg.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Success (time frame: Interval of time from access placement until any intervention is undertaken to maintain or re-establish patency - 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633304, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.