Fistulas Arteriovenous Clinical Trial
— DissolveAVFOfficial title:
Evaluation of the Safety and Efficacy of the Peripheral Scoring Drug Balloon (Dissolve AV) in Treatment of Hemodialysis Arteriovenous Fistulae Stenosis A Prospective Multicenter Randomized Controlled Clinical Study
Verified date | February 2024 |
Source | DK Medical Technology (Suzhou) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.
Status | Completed |
Enrollment | 220 |
Est. completion date | January 4, 2022 |
Est. primary completion date | October 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age = 18 years and = 75 years, male or female. - Arteriovenous fistula or Arteriovenous graft is matured and has undergone one or more hemodialysis sessions - Venous stenosis of the AV fistula or AV graft - target lesion has stenosis =50% evidenced by angiography. and have at least one symptom of these:1.Venous pressure increased significantly during dialysis,2.Abnomal phenomenon physical examination,3.Decrease in pumping blood flow. - Target lesion consists of a single lesion or a multiple lesions with target lesion length = 40 mm. Reference vessel diameter of target lesion = 4.0 mm and = 7.0 mm. - If patient has non-target lesion, the stenosis =50% and don't need to be treated. - Patient able to give informed consent Exclusion Criteria: - Women who are breastfeeding, pregnant or are intending to become pregnant - AVF located at lower limbs - two or more than two stenosis at the target vessel. - Obstruction of central venous return - ISR - AVF with acute thrombosis requiring lysis or thrombectomy in 30 days - vascular access has surgery in 30 days or intending to undergo a surgery - known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc. - Patients undergoing immunotherapy or suspected / confirmed vasculitis - Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura - Vascular access infection or systemic active infection - patients's life expectancy is less than 12 months - Renal transplantation has been planned or converted to peritoneal dialysis - Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program - involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test |
Country | Name | City | State |
---|---|---|---|
China | Emergency general hospital | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | Tongren hospital, Capital medical university | Beijing | Beijing |
China | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
China | Shaoyifu hospital, zhejiang medical universiyt | Hangzhou | Zhejiang |
China | The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
China | Huashan hospital affiliated to FuDan university | Shanghai | Shanghai |
China | Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai |
China | ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese | Shanghai | Shanghai |
China | Taiyuan Central Hospital | Taiyuan | Shanxi |
Lead Sponsor | Collaborator |
---|---|
DK Medical Technology (Suzhou) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary patency rate of the target lesion at 6 month post procedure [ Target Lesion Primary Patency ] | Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate>30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline) including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow. | 6 month | |
Secondary | Primary patency of target lesion in 12 months | Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate >30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline)including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow. | 12 Month | |
Secondary | Device success | Successful delivery to the target lesion, deployment, and retrieval at index procedure | during the procedure | |
Secondary | Clinical success | The resumption of dialysis for at least one session after the index procedure | 5 days | |
Secondary | Procedural Success | residual stenosis=30% and absence of SAE during perioperative perio | 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04698512 -
MAgicTouchâ„¢ Intervention Leap for Dialysis Access (MATILDA) Trial
|
||
Terminated |
NCT04626427 -
The WavelinQâ„¢ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
|
N/A | |
Active, not recruiting |
NCT04484220 -
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
|
N/A |