IN.PACTâ„¢ AV Access IDE Study (NCT03041467) | Clinical Trial Compass
CompletedNot Applicable
IN.PACTâ„¢ AV Access IDE Study
United States330 participantsStarted 2017-04-25
Plain-language summary
To evaluate the safety and efficacy of the IN.PACTâ„¢ 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 range21 Years
SexALL
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
✓. 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
Exclusion criteria
✕. Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
What they're measuring
1
Target Lesion Primary Patency Rate Through 6 Months