Fistula StenosisPhase 2PaciFIST-1NCT01868984
Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis
A Phase 2 study testing Paclitaxel and Standard Therapy in people with Fistula Stenosis, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula Stenosis
- What is being tested?
- Paclitaxel and Standard Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
About this study
Official title: The Use of Intravascular Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis: A Randomized Study
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.
Read more
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
- Being tested
- Paclitaxel, Standard Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
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.
Standard TherapyProcedure or surgery
Also called heparin, stents, angioplasty
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Paclitaxel; Procedure: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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.
Measured: 6 months
Primary Patency: Fistula
The interval from treatment until access thrombosis or repeat intervention treatment to maintain fistula function, or the abandonment of the fistula.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: catheters no longer available - difficult to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Spectranetics Corporation
- Responsible party
- Sponsor
- Investigators
- Kurt Wengerter, MD, Principal investigator, Englewood Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868984
- Sponsor's protocol ID
- E-12-468
- Acronym
- PaciFIST-1
- Status last verified
- Aug 2020
- First submitted
- 29 May 2013
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intravascular Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis: A Randomized Study
- ClinicalTrials.gov ID
- NCT01868984
- Acronym / sponsor ID
- PaciFIST-1 / E-12-468
- Conditions
- Fistula Stenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: catheters no longer available - difficult to recruit subjects
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Collaborators
- Spectranetics Corporation
- Study start
- May 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy Alone | Sham comparator | Procedure: Standard TherapyStandard 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. |
| Standard Therapy Plus Paclitaxel | Active comparator | Drug: Paclitaxel, Procedure: Standard TherapyStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelAlso: TaxolPaclitaxel 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. | Drug | Standard Therapy Plus Paclitaxel |
| Standard TherapyAlso: heparin, stents, angioplastyStandard 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). | Procedure or surgery | Standard Therapy Alone, Standard Therapy Plus Paclitaxel |
Primary outcome
Target Lesion Revascularization.
Time frame: 6 months
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.
Target Segment Revascularization.
Time frame: 6 months
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.
3 secondary outcomes
Overall safety based on SAEs
Time frame: 6 months
Binary Restenosis
Time frame: 6 months
Primary Patency: Fistula
Time frame: 6 months
Results and safety
The study was stopped early (reason given: catheters no longer available - difficult to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Wengerter, MD principal investigator
Englewood Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Standard Therapy in people with Fistula Stenosis, run by Englewood Hospital and Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: catheters no longer available - difficult to recruit subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Revascularization. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.