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New treatment option for Stenosis of Native Hemodialysis Arteriovenous Fistulas
Official title ACOART AVF RENEW: A Post Market Clinical Study
ClinicalTrials.gov ID: NCT06205576
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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：
- The physical examination was abnormal
You likely can't join if
- 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
- Patient has presence of a stent located in the target AV access circuit
- Patient has undergone prior intervention of access site within 30 days of index procedure
See the full eligibility criteria
- 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：
- The physical examination was abnormal
- Significant increase in dynamic venous pressure
- Blood flow decreased significantly
- Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length
- Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as:
- Residual stenosis of ≤ 30% AND
- Absence of a flow limiting dissection (Grade ≥C) or perforation
- Patient provides written informed consent prior to enrollment in the study
- 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
- Patient has presence of a stent located in the target AV access circuit
- Patient has undergone prior intervention of access site within 30 days of index procedure
- Patient with target AVF or access circuit which previously had or currently has a plan to surgery
- Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
- Patients undergoing immunotherapy or suspected/confirmed vasculitis
- Patients with a history of coagulation dysfunction, thrombocytopenic purpura or RH-negative blood type
- Patient has an infected AV access or systemic infection
- Patient has a life expectancy of \<24 months
- Patient is anticipating a kidney transplant or with anticipated conversion to peritoneal dialysis
- Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation
- Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.