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

NCT ID: NCT01929369

Last Updated: 2015-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

CONTROL GROUP

Control group: index intervention guided by DSA; IVUS post-intervention only (50 patients)

No interventions assigned to this group

TEST GROUP

Test group: index intervention guided by IVUS + DSA (50 patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patient must be > 18 and < 85 years of age

2. 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

3. 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

Exclusion Criteria

1. Patient or legally authorized representative cannot or will not provide written informed consent

2. Known metal allergy precluding endovascular stent implantation

3. Known reaction or sensitivity to iodinated contrast that cannot be pretreated

4. Patients who are pregnant or lactating

5. Patients with scheduled kidney transplant within the next 6 months

6. Patients scheduled to switch to peritoneal dialysis within the next 6 months

7. Patients with life expectancy of less than 6 months

8. Participation in any other clinical research study that would interfere with the patient's participation in this study

9. Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Volcano Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Ross, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Medical Center

Locations

Regional Medical Center

Orangeburg, South Carolina, United States

Countries

United States

Other Identifiers

Ross Pilot

Identifier Type: -

Identifier Source: org_study_id