THROMBOSED AV GRAFTSNCT01929369
Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
An observational study of THROMBOSED AV GRAFTS, run by Volcano Corporation at 1 site in United States.
Trial summary
This pilot study will provide data to aid in the planning of a follow-up multi-center randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by formal statistical hypothesis testing. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- THROMBOSED AV GRAFTS
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2014
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ESRD PATIENTS WITH THROMBOSED AV GRAFTS
Who may be able to join
- Patient must be > 18 and < 85 years of age
- Patient or legally authorized representative must be willing to participate and able to understand, read, and sign the informed consent document before the planned procedure
- Eligible for de-clot procedure or evaluation of slow flow for a failing hemodialysis graft that previously provided access for at least 1 successful hemodialysis session
Who cannot join
- Patient or legally authorized representative cannot or will not provide written informed consent
- Known metal allergy precluding endovascular stent implantation
- Known reaction or sensitivity to iodinated contrast that cannot be pretreated
- Patients who are pregnant or lactating
- Patients with scheduled kidney transplant within the next 6 months
- Patients scheduled to switch to peritoneal dialysis within the next 6 months
Show all 9Show fewer
- Patients with life expectancy of less than 6 months
- Participation in any other clinical research study that would interfere with the patient's participation in this study
- Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study will provide data to aid in the planning of a follow-up multi-center randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm) was derived in consultation with the study PI and Co-PI who are experts in vascular surgery, and in particular, the field of hemodialysis access interventions. The results of this pilot study will provide the data that is necessary for generation of specific hypotheses that can then be formally tested in the follow-up RCT
- Conditions
- THROMBOSED AV GRAFTS
- Keywords
- ESRD, CKD, AV GRAFTS, THROMBOSED AV GRAFTS
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Control group: index intervention guided by DSA; IVUS post-intervention only (50 patients) | |
| TEST GROUP | Test group: index intervention guided by IVUS + DSA (50 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-Intervention Control vs. Test
Difference in time (measured in days) to AV graft failure after index intervention guided by DSA in the absence (control group) or presence of IVUS guidance (test group), assessed through 6 months post-index procedure
Measured: 6 months
Define IVUS workflow
Define IVUS workflow for AV graft evaluation during interventions for access site failure
Measured: Day 0
Evaluate ability of IVUS in AV Grafts
Evaluate the ability of IVUS to identify targets for therapy in poorly functioning AV grafts that are not identified by DSA
Measured: Day 0
Secondary outcomes (3)
IVUS vs DSA alone- Decision making
Percentage of time IVUS changes decision making during the index procedure (test group)
Measured: Day 0
% patients requiring re-intervention
Percentage of patients with graft failure or need for reintervention at 3 months and 6 months (c0ntrol and test)
Measured: 3 months and 6 months
Assess CHROMOFLO in AV grafts
Assess the ability of ChromaFlo® to identify residual thrombus in the hemodialysis access circuit
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THROMBOSED AV GRAFTSStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Ross, MD, Principal investigator, Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929369
- Sponsor's protocol ID
- Ross Pilot
- Status last verified
- Feb 2015
- First submitted
- 22 Aug 2013
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
- ClinicalTrials.gov ID
- NCT01929369
- Acronym / sponsor ID
- Ross Pilot
- Conditions
- THROMBOSED AV GRAFTS
- Keywords
- ESRD, CKD, AV GRAFTS, THROMBOSED AV GRAFTS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Aug 2013 (estimated)
- 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 pilot study will provide data to aid in the planning of a follow-up multi-center randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm) was derived in consultation with the study PI and Co-PI who are experts in vascular surgery, and in particular, the field of hemodialysis access interventions. The results of this pilot study will provide the data that is necessary for generation of specific hypotheses that can then be formally tested in the follow-up RCT
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | – | –Control group: index intervention guided by DSA; IVUS post-intervention only (50 patients) |
| TEST GROUP | – | –Test group: index intervention guided by IVUS + DSA (50 patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ESRD PATIENTS WITH THROMBOSED AV GRAFTS
Key inclusion criteria (3 listed)
- Patient must be > 18 and < 85 years of age
- Patient or legally authorized representative must be willing to participate and able to understand, read, and sign the informed consent document before the planned procedure
- Eligible for de-clot procedure or evaluation of slow flow for a failing hemodialysis graft that previously provided access for at least 1 successful hemodialysis session
Key exclusion criteria (9 listed)
- Patient or legally authorized representative cannot or will not provide written informed consent
- Known metal allergy precluding endovascular stent implantation
- Known reaction or sensitivity to iodinated contrast that cannot be pretreated
- Patients who are pregnant or lactating
- Patients with scheduled kidney transplant within the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Re-Intervention Control vs. Test
Time frame: 6 months
Difference in time (measured in days) to AV graft failure after index intervention guided by DSA in the absence (control group) or presence of IVUS guidance (test group), assessed through 6 months post-index procedure
Define IVUS workflow
Time frame: Day 0
Define IVUS workflow for AV graft evaluation during interventions for access site failure
Evaluate ability of IVUS in AV Grafts
Time frame: Day 0
Evaluate the ability of IVUS to identify targets for therapy in poorly functioning AV grafts that are not identified by DSA
3 secondary outcomes
IVUS vs DSA alone- Decision making
Time frame: Day 0
% patients requiring re-intervention
Time frame: 3 months and 6 months
Assess CHROMOFLO in AV grafts
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
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.
John Ross, MD principal investigator
Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of THROMBOSED AV GRAFTS, run by Volcano Corporation 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 3 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: finished, as of the sponsor's last update on 20 Feb 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-Intervention Control vs. Test (time frame: 6 months). The study lists 3 primary outcomes in all. 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 20 Feb 2015.