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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03041467




Registration number
NCT03041467
Ethics application status
Date submitted
1/02/2017
Date registered
2/02/2017
Date last updated
27/02/2020

Titles & IDs
Public title
IN.PACT™ AV Access Study
Scientific title
Randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
Secondary ID [1] 0 0
APV-IN.PACT AV Access
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arteriovenous Fistula Stenosis 0 0
Arteriovenous Fistula Occlusion 0 0
Arteriovenous Fistula 0 0
Fistula 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - IN.PACT AV DCB
Treatment: Devices - Standard Balloon Angioplasty

Experimental: IN.PACT AV DCB - PTA will be performed using the IN.PACT AV Access Drug Coated Balloon. IN.PACT AV Access DCB was the device name used during the clinical study. Medtronic has changed the name of the device to IN.PACT™ AV Paclitaxel-Coated Balloon Catheter (also referred as IN.PACT AV DCB). Hence, throughout posting, the study device will be referred to as the "IN.PACT AV DCB."

Active Comparator: Standard Balloon Angioplasty - PTA will be performed using a commercially available uncoated PTA balloon.


Treatment: Devices: IN.PACT AV DCB
IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

Treatment: Devices: Standard Balloon Angioplasty
Standard PTA Balloon

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Target Lesion Primary Patency Though 6 Months - Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
Timepoint [1] 0 0
6 Months Post-Procedure
Primary outcome [2] 0 0
Primary Safety Endpoint - Serious Adverse Event Rate - Serious Adverse Event (SAE) rate involving the AV access circuit
Timepoint [2] 0 0
30 days post procedure
Secondary outcome [1] 0 0
Access Circuit Primary Patency - Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-procedure. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Timepoint [1] 0 0
3, 6, 9, 12, 18, and 24 Months
Secondary outcome [2] 0 0
Target Lesion Primary Patency - Percent of subjects with freedom from clinical drive target lesion revascularization or access thrombosis occurring in the target lesion. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Timepoint [2] 0 0
3, 9, 12, 18, and 24 Months
Secondary outcome [3] 0 0
Cumulative Target Lesion Revascularizations - The proportion of subjects with target lesion revascularizations. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Timepoint [3] 0 0
3, 6, 9, 12, 18, and 24 Months
Secondary outcome [4] 0 0
Total Number of Interventions Required to Maintain Target Lesion Patency - The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-procedure. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Timepoint [4] 0 0
3, 6, 9, 12, 18, and 24 Months
Secondary outcome [5] 0 0
Total Number of Interventions Required to Maintain Access Circuit Patency - The number of re-interventions in the target lesion and/or access circuit. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Timepoint [5] 0 0
3, 6, 9, 12, 18, and 24 Months
Secondary outcome [6] 0 0
Cumulative Access Circuit Thromboses - Proportion of subjects with access circuit thrombosis. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Timepoint [6] 0 0
3, 6, 9, 12, 18, and 24 Months
Secondary outcome [7] 0 0
Device Success - Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.
Timepoint [7] 0 0
Time of Procedure
Secondary outcome [8] 0 0
Procedure Success - Maintenance of patency (=30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
Timepoint [8] 0 0
Time of Procedure
Secondary outcome [9] 0 0
Clinical Success - Resumption of successful dialysis for at least one session after index procedure.
Timepoint [9] 0 0
From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
Secondary outcome [10] 0 0
Rate of Device Related Adverse Events - Device Related Adverse Event Rate: defined as proportion of subjects with device related Adverse Events. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Timepoint [10] 0 0
30 days, 3, 6, 9, 12, 18, and 24 Months.
Secondary outcome [11] 0 0
Procedure Related Adverse Event Rate - Procedure Related Adverse Event Rate: defined as proportion of subjects with procedure related Adverse Events reported post-index procedure until the first successful dialysis session. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Timepoint [11] 0 0
30 Days, 3, 6, 9, 12, 18, and 24 Months

Eligibility
Key inclusion criteria
1. Patient is =21 years of age.

2. Patient has a life expectancy of = 12 months

3. Patient has a native AV fistula created = 60 days prior to the index procedure

4. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions
during a four week period

5. Patient has a de novo and/or non-stented restenotic lesion located between the
arteriovenous anastomosis and axillosubclavian junction with =50% stenosis. Note: If
the lesion is located in the anastomosis, the treatment may be delivered up to 2 cm
upstream on the arterial end. If the lesion is located in the cephalic arch, the
treatment may be delivered up to 2 cm into the subclavian vein

6. Patient has a target lesion or a tandem lesion that is = 100 mm in length (by visual
estimate) Note: Tandem lesions may be enrolled provided they meet all of the following
criteria: Separated by a gap of = 30mm (3 cm), total combined lesion length, including
30 mm gap, = 100 mm, and able to be treated as a single lesion

7. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate). Note:
tandem lesions may be enrolled provided they meet all of the following criteria:
Separated by a gap of = 30 mm (3 cm), total combined lesion length, including 30 mm
gap, is = 100mm, and able to be treated as a single lesion

8. Patient underwent successful crossing of the target lesion with the guide wire and
pre-dilatation with a high pressure PTA balloon defined as: residual stenosis of = 30%
and absence of a flow limiting dissection (Grade = C) or perforation

9. Patient provides written consent prior to enrollment in the study

10. Patient is willing to comply with all follow-up evaluations at specified times
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are breastfeeding, pregnant, or are intending to become pregnant, or men
intending to father children

2. Patient is receiving immunosuppressive therapy

3. Patient is anticipating a kidney transplant within 6 months of enrollment into the
study

4. Patient has undergone prior intervention of access site within 30 days of index
procedure

5. Patient with anticipated conversion to peritoneal dialysis

6. Patient has an infected AV access or systemic infection

7. Patient has planned surgical revision of access site

8. Patient with secondary non-target lesion requiring treatment within 30-days post index
procedure

9. Patient with hemodynamically significant central venous stenoses that cannot be
successfully treated prior to treatment of the target lesion

10. Patient with target AVF or access circuit which previously had or currently has a
thrombosis

11. Patients judged to have a lesion that prevents complete inflation of an angioplasty
balloon or proper placement of the delivery system

12. Patient with target lesion located central to the axillosubclavian junction

13. Patient has significant arterial inflow lesion requiring treatment more than 2 cm
upstream from the anastomosis in the AV access

14. Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion
site

15. Patient has presence of a stent located in the target AV access circuit

16. Patients with known allergies or sensitivities to paclitaxel

17. Patient with known contraindication, including allergic reaction, or sensitivity to
contrast material that cannot be adequately pre-treated

18. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy

19. Patient with clinically significant Steal Syndrome requiring treatment

20. Patient is enrolled in another investigational drug, device, or biological study and
has not completed the primary endpoint, or was previously enrolled in this study

21. Patient has a comorbid-condition that, in the judgment of the Investigator, may cause
him/her to be non-compliant with the protocol of confound data interpretation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
South Dakota
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Japan
State/province [18] 0 0
Amagasaki
Country [19] 0 0
Japan
State/province [19] 0 0
Kamakura
Country [20] 0 0
Japan
State/province [20] 0 0
Kishiwada
Country [21] 0 0
Japan
State/province [21] 0 0
Saitama
Country [22] 0 0
Japan
State/province [22] 0 0
Shizuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
New Zealand
State/province [24] 0 0
Auckland
Country [25] 0 0
New Zealand
State/province [25] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Endovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB)
compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting
with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis
fistulae (AVF) in the upper extremity.
Trial website
https://clinicaltrials.gov/show/NCT03041467
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Lookstein, MD
Address 0 0
The Mount Sinai Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications