Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

Renal Failure Chronic Requiring Hemodialysis Clinical Trial

Official title:

A Comparison Between the HeRO® Graft and Conventional Arteriovenous Grafts in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890045
• Other study ID #: 11-0004
• Status: Completed
• Phase: N/A
• Start date: July 2004
• Est. completion date: March 2008

Study information

• Verified date: January 2024
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the HeRO Vascular Access Device to a conventional ePTFE graft.

Description:

The purpose of this study is to compare the HeRO Vascular Access Device to a conventional ePTFE graft. It is hypothesized that HeRO patency will be comparable to the conventional ePTFE graft control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 99 Years

Eligibility

Inclusion Criteria:

1. 22 years of age or older.

2. Male or non-pregnant female.

3. Life expectancy 2 years.

4. End-stage renal disease requiring an arm vascular prosthesis for dialysis access.

5. Ability to understand and provide written informed consent.

6. Willing and able to cooperate with follow-up examinations.

7. Subject's upper arm can be used for implant (Note: The GVAS device must be implanted in the upper arm only, but the Control group graft can be implanted in the upper or lower arm location.).

8. Able to follow a daily aspirin and/or other oral anticoagulation/antiplatelet regimen.

Exclusion Criteria:

1. Potential graft target artery less than 3 mm in diameter determined by any suitable preoperative measure.

2. Documented history of drug abuse within six months.

3. "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.

4. Currently being treated with another investigational device or drug.

5. Known bleeding diathesis or hypercoagulable state.

6. Peripheral white blood cell count 1500/mm3 (1.5 K/mm3) or platelet counts 50,000/mm3 (50 K/mm3).

7. Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be included.

8. Subjects with known or suspected concomitant bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B may be included. Subjects who are HIV + with CD4 count of <200 are excluded.

9. Severe underlying co-morbidity or immediate life-threatening condition.

10. Subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety.

11. Subjects who are candidates for autologous fistulas.

12. Subjects with scheduled renal transplant within the next 12 months.

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis

Intervention

Device:
• HeRO Vascular Access Device
HeRO Vascular Access Device
• Conventional ePTFE hemodialysis graft
Conventional ePTFE hemodialysis graft

Locations

Country	Name	City	State
United States	St. Joseph's Hospital	Atlanta	Georgia
United States	Seton/Brackenridge Hospitals	Austin	Texas
United States	Duke Medical Center	Durham	North Carolina
United States	Baylor Medical Center/Methodist Hospital	Houston	Texas
United States	St. Vincent's Medical Center	Los Angeles	California
United States	University of Miami/Cedars Medical Center	Miami	Florida
United States	Sentara Heart Hospital	Norfolk	Virginia
United States	North Memorial Medical Center	Robbinsdale	Minnesota
United States	Holy Cross Hospital	Rockville	Maryland
United States	Baptist Medical Center	San Antonio	Texas
United States	Southern Illinois Unversity	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.	CryoLife, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nassar GM, Glickman MH, McLafferty RB, Croston JK, Zarge JI, Katzman HE, Peden EK, Lawson JH, Martinez JM, Thackeray L. A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients. Semin Dial. 2014 May-Jun;27(3):310- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Primary Patency	Primary patency was defined as the interval of time from access placement until any intervention designed to maintain or reestablish patency, access thrombosis, or the time of measurement of patency.	6 months, 12 months
Primary	Percentage of Patients With Assisted Primary Patency	Assisted primary patency was defined as the interval of time from access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (i.e., surgical or endovascular interventions) designed to maintain the functionality of a patent access.	6 months, 12 months
Primary	Percentage of Patients With Secondary Patency	Secondary patency was defined as the interval of time from access placement until access abandonment, thrombosis, or the time of patency measurements including intervening surgical or endovascular interventions designed to reestablish functionality in a thrombosed access.	12 months
Primary	Number of Patients With Serious Device or Implant Procedure-related Adverse Events	Serious adverse events were defined as events that required hospitalization =24 hours, prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, were considered life-threatening, or resulted in death.	12 months
Secondary	Adequacy of Dialysis	Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water	12 months