Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts

NCT01929369 | Completed

• 1 other identifier: Ross Pilot
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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

  6 months

• Define IVUS workflow

  Define IVUS workflow for AV graft evaluation during interventions for access site failure

  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

  Day 0

Secondary Outcomes (3)

• IVUS vs DSA alone- Decision making

  Day 0

• % patients requiring re-intervention

  3 months and 6 months

• Assess CHROMOFLO in AV grafts

  Day 0

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ESRD PATIENTS WITH THROMBOSED AV GRAFTS

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Volcano Corporation: lead

Study Sites (1)

Regional Medical Center

Orangeburg, South Carolina, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Ross, MD

  Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 27, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 20, 2015

Record last verified: 2015-02

Locations

US (1)