Arteriovenous Fistula StenosisNCT03041467

IN.PACT™ AV Access IDE Study

A study testing IN.PACT AV DCB and Standard Balloon Angioplasty in people with Arteriovenous Fistula Stenosis and Arteriovenous Fistula Occlusion, run by Medtronic Endovascular at 29 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Arteriovenous Fistula
What is being tested?: IN.PACT AV DCB and Standard Balloon Angioplasty
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 330 participants
Where: 29 sitesin 3 countries
Study dates: 25 Apr 2017to 5 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is ≥21 years of age.
Patient has a life expectancy of ≥ 12 months
Patient has a native AV fistula created ≥ 60 days prior to the index procedure
The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period
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
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

Show all 10Show fewer

Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate).
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
Patient provides written consent prior to enrollment in the study
Patient is willing to comply with all follow-up evaluations at specified times

Who cannot join

Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
Patient is receiving immunosuppressive therapy
Patient is anticipating a kidney transplant within 6 months of enrollment into the study
Patient has undergone prior intervention of access site within 30 days of index procedure
Patient with anticipated conversion to peritoneal dialysis
Patient has an infected AV access or systemic infection

Show all 21Show fewer

Patient has planned surgical revision of access site
Patient with secondary non-target lesion requiring treatment within 30-days post index procedure
Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
Patient with target AVF or access circuit which previously had or currently has a thrombosis
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
Patient with target lesion located central to the axillosubclavian junction
Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access
Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site
Patient has presence of a stent located in the target AV access circuit
Patients with known allergies or sensitivities to paclitaxel
Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated
Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
Patient with clinically significant Steal Syndrome requiring treatment
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
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

Trial locations and contacts

29 sites in 3 countries.

Country

City, postcode or hospital

29 sites in 3 countries

United States21 sites

King's Daughters Medical Center
Ashland, Kentucky, 41101
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233
Christie Clinic Vein and Vascular Center
Champaign, Illinois, 61822
University Surgical Associates
Chattanooga, Tennessee, 37404
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Florida Research Network
Gainesville, Florida, 32605
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
The Mount Sinai Hospital
New York, New York, 10029
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Richmond Vascular Center
North Chesterfield, Virginia, 23236
Dialysis Access Institute
Orangeburg, South Carolina, 29118
Coastal Vascular and Interventional
Pensacola, Florida, 32504
Dallas Nephrology Associates
Plano, Texas, 75093
North Carolina Nephrology PA
Raleigh, North Carolina, 27610
Mayo Clinic
Rochester, Minnesota, 55905
Capital Nephrology Medical Group
Sacramento, California, 95825
Sanford University of South Dakota Medical Center
Sioux Falls, South Dakota, 57105
Holy Name Medical Center
Teaneck, New Jersey, 07666
SKI Vascular Center
Tempe, Arizona, 85281
Vascular Institute of Virginia
Woodbridge, Virginia, 22193

Other trials in United States

Japan6 sites

Kansai Rosai Hospital
Amagasaki
Shonan Kamakura General Hospital
Kamakura
Kishiwada Tokushukai Hospital
Kishiwada
Saitama Medical Center Saitama Medical University
Saitama
Shizuoka General Hospital
Shizuoka
Tokyo Women's Medical University Hospital
Tokyo

Other trials in Japan

New Zealand2 sites

Auckland City Hospital
Auckland
Capital and Coast District Health Board
Wellington

Other trials in New Zealand

About this study

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)

Read the detailed 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.

Conditions: Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Arteriovenous Fistula, Fistula
Being tested: IN.PACT AV DCB, Standard Balloon Angioplasty
Medical subject headings: Arteriovenous Fistula, Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IN.PACT AV DCBDevice
IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
Standard Balloon AngioplastyDevice
Standard PTA Balloon

Study groups in NCT03041467
Study group	Role	What they receive
IN.PACT AV DCB	Experimental	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." Receives: Device: IN.PACT AV DCB
Standard Balloon Angioplasty	Active comparator	PTA will be performed using a commercially available uncoated PTA balloon. Receives: Device: Standard Balloon Angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 Months Post-Procedure
Primary Safety Endpoint - Serious Adverse Event Rate
Serious Adverse Event (SAE) rate involving the AV access circuit
Measured: 30 days post procedure

Secondary outcomes (17)

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.
Measured: 3, 6, 9, 12, 18, and 24 Months
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.
Measured: 3, 9, 12, 18, and 24 Months
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.
Measured: 3, 6, 9,12, 18, and 24 Months
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.
Measured: 3, 6, 9, 12, 18, and 24 Months
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.
Measured: 3, 6, 9, 12, 18, and 24 Months
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.
Measured: 3, 6, 9, 12, 18, and 24 Months
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.
Measured: Time of Procedure
Procedure Success
Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
Measured: Time of Procedure
Clinical Success
Resumption of successful dialysis for at least one session after index procedure.
Measured: 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.
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.
Measured: 30 days, 3, 6, 9, 12, 18, and 24 Months.
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.
Measured: 30 Days, 3, 6, 9, 12, 18, and 24 Months
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.
Measured: 6, 9, 12, 18, 24, and 36 Months
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
Measured: 6, 9, 12, 18, 24, and 36 Months
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.
Measured: 6, 9, 12, 18, 24, and 36 Months
Abandonment of Target AVF
Defined as number of participants with abandonment of the target AV up to 36 months post-index procedure.
Measured: 6, 9, 12, 18, 24, and 36 Months
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.
Measured: 6, 12, 24, and 36 Months
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, 48 months, and 60 months.
Measured: 6, 12, 24, 36, 48, and 60 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 20175 May 2023

First posted2 Feb 2017 (estimated)
Study start25 Apr 2017
Primary completion6 Dec 2018
Study completion5 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Arteriovenous 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 330 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03041467
Sponsor's protocol ID: APV-IN.PACT AV Access
Status last verified: Jun 2023
First submitted: 1 Feb 2017
Last updated: 29 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Holden A, Haruguchi H, Suemitsu K, Isogai N, Hull J, Wiechmann BN, Wang H, Seamans J, Lookstein R; on behalf IN.PACT AV Access Investigators. IN.PACT AV Access randomized trial update: 3-year clinical results by anatomic and demographic subsets and 5-year extension mortality analysis. CVIR Endovasc. 2026 Aug 19;9(1):105. doi: 10.1186/s42155-026-00746-z.
PubMed 42616238
Holden A, Haruguchi H, Suemitsu K, Isogai N, Hull J, Wiechmann BN, Wang H, Wall B, Lookstein R; IN.PACT AV Access Investigators. Vessel and balloon sizing in the IN.PACT AV access trial: post-hoc analysis of procedural characteristics and outcomes. CVIR Endovasc. 2026 Feb 14;9(1):17. doi: 10.1186/s42155-026-00650-6.
PubMed 41689689
Lookstein RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S, Holden A; IN.PACT AV Access Investigators. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med. 2020 Aug 20;383(8):733-742. doi: 10.1056/NEJMoa1914617.
PubMed 32813949

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arteriovenous Fistula Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03041467
Acronym / sponsor ID: APV-IN.PACT AV Access
Conditions: Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Arteriovenous Fistula, Fistula
Study type: Interventional
Recruitment status: Completed
Enrolment: 330 participants (actual)
Lead sponsor: Medtronic EndovascularIndustry (pharma, biotech, devices)
Study start: 25 Apr 2017 (actual)
Primary completion: 6 Dec 2018 (actual)
Study completion: 5 May 2023 (actual)
First posted: 2 Feb 2017 (estimated)
Results: Posted 27 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
IN.PACT AV DCB	Experimental	Device: IN.PACT AV DCBPTA 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."
Standard Balloon Angioplasty	Active comparator	Device: Standard Balloon AngioplastyPTA will be performed using a commercially available uncoated PTA balloon.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patient is ≥21 years of age.
Patient has a life expectancy of ≥ 12 months
Patient has a native AV fistula created ≥ 60 days prior to the index procedure
The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period
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

Key exclusion criteria (21 listed)

Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
Patient is receiving immunosuppressive therapy
Patient is anticipating a kidney transplant within 6 months of enrollment into the study
Patient has undergone prior intervention of access site within 30 days of index procedure
Patient with anticipated conversion to peritoneal dialysis

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

Primary outcome

Target Lesion Primary Patency Rate Through 6 Months
Time frame: 6 Months Post-Procedure
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
Primary Safety Endpoint - Serious Adverse Event Rate
Time frame: 30 days post procedure
Serious Adverse Event (SAE) rate involving the AV access circuit

17 secondary outcomes

Access Circuit Primary Patency
Time frame: 3, 6, 9, 12, 18, and 24 Months
Target Lesion Primary Patency
Time frame: 3, 9, 12, 18, and 24 Months
Cumulative Target Lesion Revascularizations
Time frame: 3, 6, 9,12, 18, and 24 Months
Total Number of Interventions Required to Maintain Target Lesion Patency
Time frame: 3, 6, 9, 12, 18, and 24 Months
Total Number of Interventions Required to Maintain Access Circuit Patency
Time frame: 3, 6, 9, 12, 18, and 24 Months
Cumulative Access Circuit Thromboses
Time frame: 3, 6, 9, 12, 18, and 24 Months
Device Success
Time frame: Time of Procedure
Procedure Success
Time frame: Time of Procedure
Clinical Success
Time frame: 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.
Rate of Device Related Adverse Events
Time frame: 30 days, 3, 6, 9, 12, 18, and 24 Months.
Procedure Related Adverse Event Rate
Time frame: 30 Days, 3, 6, 9, 12, 18, and 24 Months
Target Lesion Revascularizations (TLR)
Time frame: 6, 9, 12, 18, 24, and 36 Months
Clinically-Driven Target Lesion Revascularizations (CD-TLR)
Time frame: 6, 9, 12, 18, 24, and 36 Months
Re-interventions in the Access Circuit
Time frame: 6, 9, 12, 18, 24, and 36 Months
Abandonment of Target AVF
Time frame: 6, 9, 12, 18, 24, and 36 Months
Serious Adverse Event Rate
Time frame: 6, 12, 24, and 36 Months
Rate of Freedom From All-Cause Mortality Post Vital Status Update
Time frame: 6, 12, 24, 36, 48, and 60 Months

Results and safety

Results posted to the registry on 27 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IN.PACT AV DCB	170	57
Standard Balloon Angioplasty	160	41

Primary outcome: Target Lesion Primary Patency Rate Through 6 Months

Time frame: 6 Months Post-Procedure. Count of participants. Unit: Participants

Measure	IN.PACT AV DCB n = 152	Standard Balloon Angioplasty n = 148
Value	125	88

IN.PACT AV DCB vs Standard Balloon Angioplasty: p <0.001, One-sided Z-test

Population analysed: Evaluable subjects were all subjects with events or subjects without events but had at least 150 days of clinical follow-up were counted as evaluable subjects. If a subject had no event and abandoned AV Access circuit within 150 days the subject will be considered not evaluable for 6-months effectiveness endpoints.

Primary outcome: Primary Safety Endpoint - Serious Adverse Event Rate

Time frame: 30 days post procedure. Count of participants. Unit: Participants

Measure	IN.PACT AV DCB n = 166	Standard Balloon Angioplasty n = 158
Value	7	7

IN.PACT AV DCB vs Standard Balloon Angioplasty: p = 0.002, Farrington-Manning Test

Population analysed: All subjects with events or subjects without events but had at least 23 days of clinical follow-up were counted as evaluable subjects.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IN.PACT AV DCB	148 of 170 (87.1%)	31 of 170 (18.2%)	59 of 170
Standard Balloon Angioplasty	143 of 160 (89.4%)	32 of 160 (20%)	60 of 160

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42616238Holden A, Haruguchi H, Suemitsu K, Isogai N, Hull J, Wiechmann BN, Wang H, Seamans J, Lookstein R; on behalf IN.PACT AV Access Investigators. IN.PACT AV Access randomized trial update: 3-year clinical results by anatomic and demographic subsets and 5-year extension mortality analysis. CVIR Endovasc. 2026 Aug 19;9(1):105. doi: 10.1186/s42155-026-00746-z.
Derived from this study: PubMed 41689689Holden A, Haruguchi H, Suemitsu K, Isogai N, Hull J, Wiechmann BN, Wang H, Wall B, Lookstein R; IN.PACT AV Access Investigators. Vessel and balloon sizing in the IN.PACT AV access trial: post-hoc analysis of procedural characteristics and outcomes. CVIR Endovasc. 2026 Feb 14;9(1):17. doi: 10.1186/s42155-026-00650-6.
Derived from this study: PubMed 32813949Lookstein RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S, Holden A; IN.PACT AV Access Investigators. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med. 2020 Aug 20;383(8):733-742. doi: 10.1056/NEJMoa1914617.
Individual participant dataSharing planned: No

Related trials for Arteriovenous Fistula Stenosis

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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.

Robert Lookstein, MD principal investigator

The Mount Sinai Hospital

Andrew Holden, MD principal investigator

Auckland City Hospital

Hiroaki Haruguchi, MD principal investigator

Haruguchi Vascular Access Clinic

29 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 21 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: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Japan, New Zealand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Primary Patency Rate Through 6 Months (time frame: 6 Months Post-Procedure). 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?

On the ClinicalTrials.gov record for NCT03041467, which also lists 3 linked publications.

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 29 May 2024.