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NCT01868984 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis
A Phase 2 study, sponsored by Englewood Hospital and Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01868984 is a Phase 2 study that was terminated before completion, run by Englewood Hospital and Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT01868984, a Phase 2 study, was terminated before completion, sponsored by Englewood Hospital and Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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 fistula stenosis. A fistulogram will be performed in standard fashion. The diagnostic component will include evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or graft, plus venous return up to the heart. The location, vessel size, lesion diameter and percent stenosis for each lesion will be recorded. Enrollment and randomization will occur at this point. All patients will then receive standard therapy for their stenosis. This will include intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond poorly to angioplasty (\>30% residual stenosis after angioplasty treatment with 2 inflations) will be stented. Stent selection will be based on clinical setting. Initial stent treatment will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard). Documentation of location and type of treatment for each lesion treated will be recorded. Once standard treatment is completed, the operating surgeon will be informed of the patient randomization: treatment (paclitaxel) or control. For subjects assigned to treatment, Paclitaxel solution treatment of each lesion encountered from proximal to distal will be attempted until the 20 mg Paclitaxel dose limit is met. A TAPAS infusion catheter will be used for all paclitaxel dose administrations. The TAPAS infusion catheter will be positioned to reduce the presence of branches which permit the loss of paclitaxel from the treatment zone. After the full outflow vein segment is treated, the fistulogram is completed in the standard fashion. Prior to removal of the sheath, a final angiographic study of all areas treated is performed to document patency and lesion a
Interventions
- DRUG Paclitaxel
- PROCEDURE Standard Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01868984
The ClinicalTrials.gov registry entry for NCT01868984 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Englewood Hospital and Medical Center, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT01868984 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01868984 about?
NCT01868984 is a clinical study titled "Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis". 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 fistula stenosis. A fistulogram will be performed in standard fashion. The diagnostic component will in...
What is the current status of trial NCT01868984?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2013-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01868984?
The interventions under investigation include: Paclitaxel (DRUG), Standard Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT01868984?
This trial is sponsored by Englewood Hospital and Medical Center, which has 18 total clinical trials registered on ClinicalTrials.gov.
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