Status:
TERMINATED
Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis
Lead Sponsor:
Englewood Hospital and Medical Center
Collaborating Sponsors:
Spectranetics Corporation
Conditions:
Fistula Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the use of intravascular paclitaxel, in addition to standard therapy, for the treatment of arteriovenous dialysis access fist...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Patient or guardian able to provide a signed witnessed informed consent
- Stenosis greater than or equal to 50% treated satisfactorily (less than 20% residual stenosis) with balloon angioplasty alone or balloon angioplasty and stent placement
- Either gender
Exclusion
- Women who are pregnant or who are expected to or might become pregnant
- Women of child-bearing potential who do not use contraception
- Life expectancy less than 12 months
- Known allergy to paclitaxel
- Known allergy to contrast media not previously demonstrated to be controllable with premedication on a prior study using contrast
- Known allergy to the pre-medications (dexamethasone, famotidine, diphenhydramine)
- Pre-fistulogram thrombosis of the fistula or graft
- Thrombectomy of the fistula or graft within 14 days of the procedure
- Patient receiving chemotherapy
- Patients with an immunodeficiency disease or condition
- Documented hypercoagulable state
- White Blood Count \< 2000/mm3
- Platelet count less than 100,000/mm3
- Chronic hepatitis or jaundice (total bilirubin \> 2x upper limit of normal)
- Simultaneous enrollment in another investigational device or drug study
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01868984
Start Date
May 1 2013
End Date
June 1 2015
Last Update
August 12 2020
Active Locations (1)
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1
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631