IN.PACT™ AV Access IDE Study

Arteriovenous Fistula Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041467
• Other study ID #: APV-IN.PACT AV Access
• Status: Completed
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: May 5, 2023

Study information

• Verified date: June 2023
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, global, multi-center, single-blinded, 1:1 randomized clinical trial evaluating 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. The trial will be conducted in up to 30 sites in the United States, Japan, and New Zealand.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 5, 2023
• Est. primary completion date: December 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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 side. 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).

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

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Occlusion
• Arteriovenous Fistula Stenosis
• Fistula

Intervention

Device:
• IN.PACT AV DCB
IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
• Standard Balloon Angioplasty
Standard PTA Balloon

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital	Amagasaki
Japan	Shonan Kamakura General Hospital	Kamakura
Japan	Kishiwada Tokushukai Hospital	Kishiwada
Japan	Saitama Medical Center Saitama Medical University	Saitama
Japan	Shizuoka General Hospital	Shizuoka
Japan	Tokyo Women's Medical University Hospital	Tokyo
New Zealand	Auckland City Hospital	Auckland
New Zealand	Capital and Coast District Health Board	Wellington
United States	King's Daughters Medical Center	Ashland	Kentucky
United States	University of Alabama at Birmingham (UAB) Hospital	Birmingham	Alabama
United States	Christie Clinic Vein and Vascular Center	Champaign	Illinois
United States	University Surgical Associates	Chattanooga	Tennessee
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Florida Research Network	Gainesville	Florida
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	The Mount Sinai Hospital	New York	New York
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	Richmond Vascular Center	North Chesterfield	Virginia
United States	Dialysis Access Institute	Orangeburg	South Carolina
United States	Coastal Vascular and Interventional	Pensacola	Florida
United States	Dallas Nephrology Associates	Plano	Texas
United States	North Carolina Nephrology PA	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Capital Nephrology Medical Group	Sacramento	California
United States	Sanford University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	SKI Vascular Center	Tempe	Arizona
United States	Vascular Institute of Virginia	Woodbridge	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Countries where clinical trial is conducted

United States,  Japan,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Primary Patency Rate Through 6 Months	Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.	6 Months Post-Procedure
Primary	Primary Safety Endpoint - Serious Adverse Event Rate	Serious Adverse Event (SAE) rate involving the AV access circuit	30 days post procedure
Secondary	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.	3, 6, 9, 12, 18, and 24 Months
Secondary	Target Lesion Primary Patency	Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.	3, 9, 12, 18, and 24 Months
Secondary	Cumulative Target Lesion Revascularizations	The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.	3, 6, 9,12, 18, and 24 Months
Secondary	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.	3, 6, 9, 12, 18, and 24 Months
Secondary	Total Number of Interventions Required to Maintain Access Circuit Patency	The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.	3, 6, 9, 12, 18, and 24 Months
Secondary	Cumulative Access Circuit Thromboses	The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.	3, 6, 9, 12, 18, and 24 Months
Secondary	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.	Time of Procedure
Secondary	Procedure Success	Maintenance of patency (=30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).	Time of Procedure
Secondary	Clinical Success	Resumption of successful dialysis for at least one session after index procedure.	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	Rate of Device Related Adverse Events	Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.	30 days, 3, 6, 9, 12, 18, and 24 Months.
Secondary	Procedure Related Adverse Event Rate	Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.	30 Days, 3, 6, 9, 12, 18, and 24 Months
Secondary	Target Lesion Revascularizations (TLR)	Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.	6, 9, 12, 18, 24, and 36 Months
Secondary	Clinically-Driven Target Lesion Revascularizations (CD-TLR)	Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure	6, 9, 12, 18, 24, and 36 Months
Secondary	Re-interventions in the Access Circuit	Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.	6, 9, 12, 18, 24, and 36 Months
Secondary	Abandonment of Target AVF	Defined as number of participants with abandonment of the target AV abandonment up to 36 months post-index procedure.	6, 9, 12, 18, 24, and 36 Months
Secondary	Serious Adverse Event Rate	Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.	6, 12, 24, and 36 Months
Secondary	Rate of Freedom From All-Cause Mortality Post Vital Status Update	Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, and 48 months.	6, 12, 24, 36, and 48 Months