Using drug-coated balloons to treat blockages in dialysis fistulas
A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon for the Treatment of the Obstructive Lesions in the Native Arteriovenous Dialysis Fistuae(AVF)
This study is testing if special drug-coated balloons can safely help people with blocked dialysis fistulas feel better and improve their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Acotec Scientific Co., Ltd Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06205576 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to gather data on the safety and effectiveness of Acotec Orchid and Dhalia drug-coated balloon catheters for treating stenosis in native hemodialysis arteriovenous fistulas. It is a prospective, multi-center, single-arm study that focuses on patients with obstructive lesions in their dialysis fistulas. Participants will undergo treatment with the drug-coated balloon catheter after meeting specific eligibility criteria, including having a significant blockage in their fistula. The study will monitor outcomes related to the procedure's safety and performance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with significant stenosis in their dialysis fistulas who have undergone successful dialysis.
Not a fit: Patients who are pregnant, breastfeeding, or planning to become pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve blood flow and overall function of dialysis fistulas, enhancing patient outcomes.
How similar studies have performed: Other studies using drug-coated balloons for similar vascular conditions have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Beijing
- Beijing Haidian Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Wang Yu Zhu
- Email: wangyuzhu@163.com
- Phone: 010-82693657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.