Fistula Stenosis Clinical Trial
— PaciFIST-1Official title:
The Use of Intravascular Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis: A Randomized Study
| NCT number | NCT01868984 |
| Other study ID # | E-12-468 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | May 2013 |
| Est. completion date | June 2015 |
| Verified date | August 2020 |
| Source | Englewood Hospital and Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
appearance.
For the control group, instead of paclitaxel administration, a sham treatment period of 10
minutes is allowed to elapse followed by the performance of the final completion angiogram.
Any additional lesions identified with this study are then treated appropriately following
standard technique.
All patients will follow the same follow up evaluation schedule.
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Age 18 years or older 2. Patient or guardian able to provide a signed witnessed informed consent 3. Stenosis greater than or equal to 50% treated satisfactorily (less than 20% residual stenosis) with balloon angioplasty alone or balloon angioplasty and stent placement 4. Either gender Exclusion Criteria: 1. Women who are pregnant or who are expected to or might become pregnant 2. Women of child-bearing potential who do not use contraception 3. Life expectancy less than 12 months 4. Known allergy to paclitaxel 5. Known allergy to contrast media not previously demonstrated to be controllable with premedication on a prior study using contrast 6. Known allergy to the pre-medications (dexamethasone, famotidine, diphenhydramine) 7. Pre-fistulogram thrombosis of the fistula or graft 8. Thrombectomy of the fistula or graft within 14 days of the procedure 9. Patient receiving chemotherapy 10. Patients with an immunodeficiency disease or condition 11. Documented hypercoagulable state 12. White Blood Count < 2000/mm3 13. Platelet count less than 100,000/mm3 14. Chronic hepatitis or jaundice (total bilirubin > 2x upper limit of normal) 15. Simultaneous enrollment in another investigational device or drug study |
| Country | Name | City | State |
|---|---|---|---|
| United States | Englewood Hospital and Medical Center | Englewood | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Englewood Hospital and Medical Center | Spectranetics Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Target Lesion Revascularization. | Target lesion revascularization (TLR) is defined as the need for subsequent clinically driven repeat angioplasty, stent placement or other intervention to correct the recurrence of a stenosis at the site treated within 6 months of the initial treatment. | 6 months | |
| Primary | Target Segment Revascularization. | Target segment revascularization (TSR) is defined as the need for secondary clinically driven repeat angioplasty, stent placement or other intervention to correct the recurrence of a stenosis in the outflow segment of cephalic vein treated with paclitaxel. | 6 months | |
| Secondary | Overall safety based on SAEs | The overall serious adverse event (SAE) rate will be determined as well as the rate for each individual type of adverse occurrence or event. | 6 months | |
| Secondary | Binary Restenosis | The development of recurrent stenosis of the site treated with angioplasty or angioplasty and stent followed by the paclitaxel controlled infusion. The presence of a binary stenosis is defined as a 50% decrease of the vessel diameter measured on the fistulogram. | 6 months | |
| Secondary | Primary Patency: Fistula | The interval from treatment until access thrombosis or repeat intervention treatment to maintain fistula function, or the abandonment of the fistula. | 6 months |