Dysfunctional Arterial-venous GraftsNCT04627051
Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis
A study testing Atherectomy and balloon angioplasty in people with Dysfunctional Arterial-venous Grafts, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This single-centre, single-arm, prospective study will enroll 30 subjects presenting with clinical and hemodynamic abnormalities in arteriovenous graft (AVG) in the arm. Subjects will be treated with the Jetstream™ atherectomy device and Ranger™ Drug Coated Balloons (DCB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysfunctional Arterial-venous Grafts
- What is being tested?
- Atherectomy and balloon angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 12 Nov 2020to Jan 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 non-pregnant, non-breastfeeding female ≥18 years of age;
- Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
- Target lesion must be a mature arteriovenous graft presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines;
- Subject has a target lesion at the venous anastomosis of the AVG;
- Successful crossing of the stenosis;
- Each lesion length is ≤20mm, which may include tandem lesions that are ≤20mm apart
Who cannot join
- Subject is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this study;
- Subject has a non-controllable allergy to contrast;
- Subject has more than 3 lesions in the access circuit requiring intervention;
- Target lesion diameter >10mm;
- A thrombosed access or an access with a thrombosis treated ≤30 days prior to the index procedure;
- Prior surgical interventions of the access site ≤30 days before the index procedure;
- Target lesion is located within a bare metal or covered stent.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2N2
About this study
Official title: A Prospective, Single-Centre Study Investigating the Clinical Use and Safety of the Jetstream Atherectomy With Drug Coated Balloon (Ranger) for the Treatment of Dysfunctional Arterio-Venous Graft Stenosis
This single-centre, single-arm, prospective study will enroll 30 subjects presenting with clinical and hemodynamic abnormalities in arteriovenous graft (AVG) in the arm. Subjects will be treated with the Jetstream™ atherectomy device and Ranger™ Drug Coated Balloons (DCB). Subjects will be followed up clinically via office visit or phone visit at 6 and 12 months post procedure. This study is to demonstrate safety and assess the clinical use and outcomes of the Jetstream ™atherectomy device and Ranger™ DCB for the treatment of dysfunctional AV graft.
- Conditions
- Dysfunctional Arterial-venous Grafts
- Being tested
- Atherectomy and balloon angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atherectomy and balloon angioplastyDevice
Atherectomy and balloon angioplasty of arterial-venous graft stenosis
| Study group | Role | What they receive |
|---|---|---|
| Dysfunction AV graft | Experimental | Dysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty Receives: Device: Atherectomy and balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Primary Patency (TLPP) through 6 months
50% re-stenosis of the target lesion
Measured: within 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start12 Nov 2020
- Primary completionDec 2021 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional Arterial-venous GraftsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment of Jetstream™ atherectomy device and Ranger ™ drug coated balloons
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627051
- Sponsor's protocol ID
- 20-5673
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Centre Study Investigating the Clinical Use and Safety of the Jetstream Atherectomy With Drug Coated Balloon (Ranger) for the Treatment of Dysfunctional Arterio-Venous Graft Stenosis
- ClinicalTrials.gov ID
- NCT04627051
- Acronym / sponsor ID
- 20-5673
- Conditions
- Dysfunctional Arterial-venous Grafts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 13 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 single-centre, single-arm, prospective study will enroll 30 subjects presenting with clinical and hemodynamic abnormalities in arteriovenous graft (AVG) in the arm. Subjects will be treated with the Jetstream™ atherectomy device and Ranger™ Drug Coated Balloons (DCB). Subjects will be followed up clinically via office visit or phone visit at 6 and 12 months post procedure. This study is to demonstrate safety and assess the clinical use and outcomes of the Jetstream ™atherectomy device and Ranger™ DCB for the treatment of dysfunctional AV graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment of Jetstream™ atherectomy device and Ranger ™ drug coated balloons
| Arm | Type | Receives |
|---|---|---|
| Dysfunction AV graft | Experimental | Device: Atherectomy and balloon angioplastyDysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant, non-breastfeeding female ≥18 years of age;
- Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
- Target lesion must be a mature arteriovenous graft presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines;
- Subject has a target lesion at the venous anastomosis of the AVG;
- Successful crossing of the stenosis;
Key exclusion criteria (7 listed)
- Subject is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this study;
- Subject has a non-controllable allergy to contrast;
- Subject has more than 3 lesions in the access circuit requiring intervention;
- Target lesion diameter >10mm;
- A thrombosed access or an access with a thrombosis treated ≤30 days prior to the index procedure;
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 |
|---|---|---|
| Atherectomy and balloon angioplastyAtherectomy and balloon angioplasty of arterial-venous graft stenosis | Device | Dysfunction AV graft |
Primary outcome
Target Lesion Primary Patency (TLPP) through 6 months
Time frame: within 6 months post intervention
50% re-stenosis of the target lesion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atherectomy and balloon angioplasty in people with Dysfunctional Arterial-venous Grafts, run by University Health Network, Toronto at 1 site in Canada.
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 6 inclusion and 7 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 12 Mar 2021. 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 Canada. 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 Kong Teng Tan, MD (416-340-4800 ext. 6166, kongteng.tan@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Primary Patency (TLPP) through 6 months (time frame: within 6 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2021.