An interventional study of Dissolve AV Peripheral Scoring Drug-coated Balloon in Arteriovenous Fistula Stenosis, sponsored by DK Medical Technology (Suzhou) Co., Ltd.. Recruiting at 33 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by DK Medical Technology (Suzhou) Co., Ltd. · Not applicable, Interventional, and Treatment
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Among 20 studies in Arteriovenous Fistula with a site in China — 6 open to participants now, 7 under way, none of them phase 3. Arteriovenous Fistula · China.
Among the 20 studies in Arteriovenous Fistula with a site in China, this one is the 3rd largest by planned enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2024, is one of 13 with no phase, and was the 15th registered.
248 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
Browse Arteriovenous Fistula studies →6 of the 20 studies in Arteriovenous Fistula with a site in China are open now. Recruiting first, the newest first:
Suzhou Municipal Hospital of Anhui Province · Sites in China
Ages 18–100
RenJi Hospital · Sites in China
Ages 18–75
MicroPort NeuroTech Co., Ltd. · Sites in China
Ages 18–80
Acotec Scientific Co., Ltd · Sites in China
Ages 18–85
Ai Peng · Sites in China
Ages 18–75 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 27 Arteriovenous Fistula studies recruiting now, 13 (48%) set no upper age limit and 4 (15%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 4 started in 2024.
This study's planned enrollment of 328 is above the median of 64 across 166 interventional studies indexed under Arteriovenous Fistula.
Median enrollment 184 across the 14 interventional studies, 190 across the 6 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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7 of 20 have an industry lead sponsor. The 10 most frequent:
DK Medical Technology (Suzhou) Co., Ltd. is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
DK Medical Technology (Suzhou) Co., Ltd. has 2 studies filed under Arteriovenous Fistula — fewer than ten, so there is no comparison to draw.
2 of the studies in Arteriovenous Fistula with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07372027Suzhou Municipal Hospital of Anhui ProvinceSingle-Needle Distal Return for Long-Term Arteriovenous Fistula Care | 2026-12-20 |
| NCT06422845DK Medical Technology (Suzhou) Co., Ltd.Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis | 2027-07 |
Add all 2 to your calendar (.ics) → With an account.
Among the 20 studies in Arteriovenous Fistula with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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 (SDCB) in the treatment of hemodialysis arteriovenous fistula stenosis. A total of 328 participants will be enrolled across multiple clinical trial sites. Participants will undergo a surgical procedure using a peripheral scoring drug-coated balloon dilation catheter, with follow-up within 5 days, at 1 month, and 6 months after the procedure, then at 12, 18, and 24 months post-procedure. The target lesion primary patency (TLPP) at 6 months post-procedure is the defined primary endpoint to evaluate the safety and effectiveness of the peripheral scoring drug balloon dilatation catheter.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter
Device: Dissolve AV Peripheral Scoring Drug-coated Balloon
Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon
Also known as: Scoring Drug-coated Balloon
Target Lesion Primary Patency (TLPP) at 6 months post-procedure
Target Lesion Primary Patency is defined as freedom from clinically driven Target Lesion Failure (TLF) (including +/-5mm proximal or distal of the target lesion) or Vascular Access Thrombosis. TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up, etc.
Time frame: 6 months post-procedure
Target Lesion Primary Patency (TLPP)
TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up, etc.
Time frame: 12, 24 months post-procedure
Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), so as to confirm the absence of restenosis
Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), at 6, 12, and 24 months post-procedure, so as to confirm the absence of restenosis.
Time frame: 6, 12, 24 months post-procedure
Clinically-driven Target Lesion Revascularization (CD-TLR)
Any reintervention of a target lesion (including +/-5 mm proximal or distal to the target lesion) as determined by clinical symptoms or dialysis indicators indicating that it is unable to perform dialysis.
Time frame: 1, 6, 12, 18, and 24 months post-procedure
Clinically-driven Target Shunt Revascularization (CD-TSR)
Time frame: 1, 6, 12, 18, and 24 months post-procedure
Device Success
Defined as the ability of the balloon to reach the target lesion, be successfully expanded without rupture, and be successfully withdrawn. Evaluation is based on single balloon dilation catheter.
Time frame: During the procedure
Technical Success
Defined as residual stenosis of the target lesion post-procedure is ≤ 30%, and no serious adverse events related to the trial device occurred during the perioperative period.
Time frame: 0-5 days post-procedure
Clinical Success
Defined as ability to complete at least one successful hemodialysis session post-procedure.
Time frame: 0-5 days post-procedure
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jul 2027, 34 months after the start.
Of 84 interventional studies with no phase under Arteriovenous Fistula, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 34 months is above that.
How these figures are worked out, and which studies are left out of them.
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DK Medical Technology (Suzhou) Co., Ltd.