ACOART AVF RENEW: A Post Market Clinical Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAcotec Scientific Co., Ltd
About this trial
The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).
Eligibility criteria
Qualifiers
Patient is ≥18 and ≤85 years of age
The target AV fistula has undergone successful dialysis for at least 1 time
Patient has a de novo and/or non-stented restenotic lesion located in the outflow vein（Arteries and Central Vein are excluded）
Patient has a de novo and/or non-stented restenotic lesion（≥50% stenosis）and at least one of the following occurs：
Disqualifiers
Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
Dialysis access is located in the lower extremity
More than one lesion
Patient with hemodynamically significant central venous stenoses
Trial design
Treatments tested in this trial
- DCB catheter
Treatment groups
164 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov