Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis

NCT01868984 | Terminated Phase 2

• 1 other identifier: E-12-468
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Fistula Stenosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Overall safety based on SAEs

  6 months

• Binary Restenosis

  6 months

• Primary Patency: Fistula

  6 months

Study Arms (2)

Standard Therapy Alone

SHAM COMPARATOR

Standard treatment of all stenotic lesions will be carried out in the usual fashion. Intravenous heparin will be 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). For this "control" group, no paclitaxel is administered. The sham treatment is a period of 10 minutes that is allowed to elapse followed by the performance of a final completion angiogram to be labeled as "PaciFIST Study Completion Angiogram." Any additional lesions identified with this study are then treated appropriately following standard technique.

Procedure: Standard Therapy

Standard Therapy Plus Paclitaxel

ACTIVE COMPARATOR

Standard treatment of all stenotic lesions will be carried out in the usual fashion. Intravenous heparin will be 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). For this "treatment" group, Paclitaxel solution treatment of each lesion encountered from proximal to distal will be attempted until the 20 mg Paclitaxel dose limit is met.

Drug: Paclitaxel; Procedure: Standard Therapy

Interventions

Paclitaxel DRUG

Paclitaxel solution treatment of each lesion encountered will be attempted until the 20 mg Paclitaxel dose limit is met. The volume administered will depend on the diameter and length of the venous outflow segment.

Also known as: Taxol

Standard Therapy Plus Paclitaxel

Standard Therapy PROCEDURE

Standard treatment of all stenotic lesions will be carried out in the usual fashion. Intravenous heparin will be 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).

Also known as: heparin, stents, angioplasty

Standard Therapy Alone; Standard Therapy Plus Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Englewood Hospital and Medical Center: lead
• Spectranetics Corporation: collaborator

Study Sites (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Paclitaxel; Standard of Care; Heparin; Stents; Angioplasty

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Glycosaminoglycans; Polysaccharides; Carbohydrates; Prostheses and Implants; Equipment and Supplies; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Kurt Wengerter, MD

  Englewood Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 5, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

US (1)