BridgeMD
New treatment option for Arteriovenous Fistula Stenosis
Official title Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
ClinicalTrials.gov ID: NCT06422845
What this study is testing
- What it's testing
- This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.
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 80
You may be able to join if
- Age ≥ 18 and ≤ 80 years old;
- The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
- The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
- Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical...
- The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60...
You likely can't join if
- Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
- Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
- Calcified lesions that are not expected to be expandable with balloons;
- Patients with thrombosis at the access stenosis site;
- The target lesion is located at the blood supply artery and arterial anastomosis;
- Patients known to be allergic to or intolerant to contrast media and paclitaxel;
See the full eligibility criteria
- Age ≥ 18 and ≤ 80 years old;
- The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
- The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
- Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase...
- The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion);
- Visual inspection of the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤ 60mm;
- The patient voluntarily signs the informed consent form.
- Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
- Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
- Calcified lesions that are not expected to be expandable with balloons;
- Patients with thrombosis at the access stenosis site;
- The target lesion is located at the blood supply artery and arterial anastomosis;
- Patients known to be allergic to or intolerant to contrast media and paclitaxel;
- The patient's life expectancy is less than 2 years;
- Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis;
- Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis;
- Vascular access infection or systemic active infection;
- Those who have participated in unfinished clinical trials of other drugs or devices;
- Patients with other medical conditions that the investigator believes are not suitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guanzhou, Guangdong, China
- Huizhou, Guangdong, China
- Shenzhen, Guangdong, China
- Liuzhou, Guangxi, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Xi'an, Shaanxi, China
- Dezhou, Shandong, China
- Jinan, Shandong, China
- Qingdao, Shandong, China
- Rizhao, Shandong, China
- Taiyuan, Shanxi, China
+ 7 more site(s).
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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guanzhou, Guangdong, China; Huizhou, Guangdong, China; Shenzhen, Guangdong, China and 21 more location(s). 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.