CompletedNot Applicable

IN.PACT™ AV Access IDE Study

United States, Japan, New Zealand330 participantsStarted 2017-04-25

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Target Lesion Primary Patency Rate Through 6 Months

Timeframe: 6 Months Post-Procedure

Primary Safety Endpoint - Serious Adverse Event Rate

Timeframe: 30 days post procedure

Trial details

NCT IDNCT03041467

SponsorMedtronic Endovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-06

Results submitted2019-12-06

View on ClinicalTrials.gov More Arteriovenous Fistula Stenosis trials

Plain-language summary

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

IN.PACT™ AV Access IDE Study

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

IN.PACT™ AV Access IDE Study

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria