Fistulas ArteriovenousDissolveAVFNCT04226599

A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV

A study testing Dissolve AVF and Armada 35 in people with Fistulas Arteriovenous, run by DK Medical Technology (Suzhou) Co., Ltd. at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Fistulas Arteriovenous
What is being tested?: Dissolve AVF and Armada 35
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 10 sitesChina
Study dates: 23 Jul 2019to 4 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-75 years (inclusive), male or female;
Patients with mature AVF/AVG and at least one successful hemodialysis session;
Target lesion located in the AVF/AVG reflux vein (excluding the feeding artery and central vein);
With hemodynamically significant AVF/AVG stenosis and meeting two of the following conditions (A \& B) A. ≥ 50% stenosis of the target lesion as assessed by angiography B. Presence of at least one of the following (as defined in the NKF-K/DOQI guidelines) 1)Significantly elevated venous pressure during dialysis 2)Unexplained decrease in dialysis dose 3)Decrease in pump-controlled blood flow;
De novo or restenotic target lesion consisting of one or more tandem lesions, and with a visual reference vessel diameter of 4.0-8.0 mm and a total length ≤ 40 mm for the target lesion;
All non-target lesions must have <50% stenosis without clinical indication for treatment.
Patients who have signed the informed consent form.

Who cannot join

Patients who are participating in another clinical trial of a drug product or medical device;
Patients previously enrolled in this trial;
Women of childbearing age with a non-negative pregnancy test prior to surgical procedure, or lactating women;
Patients treated with major surgeries (e.g., open-heart surgery, cranial surgery) within 30 days prior to enrollment in the study;
Immature AVF/AVG (not subjected to dialysis; this vascular access has not been subjected to a single successful dialysis due to insufficient inner diameter that prevents successful puncture and results in inadequate blood flow);
Calcified lesions that are not expected to be dilated with a balloon;

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AVF/AVG implanted with a stent;
AVF/AVG lesions previously treated with DCB;
Target lesions located at the venous anastomosis of AVF/AVG;
Impaired central venous reflux ;
Presence of a stenotic lesion in the artery that severely interferes with blood flow;
Patients with known allergy or intolerance to paclitaxel or contrast agent;
Patients with a life expectancy of less than 1 year;
Patients with concomitant systemic lupus erythematosus (SLE), ANCA-associated small vessel vasculitis;
Patients with a history of coagulopathy or thrombocytopenic purpura;
Patients treated with or scheduled to be treated with renal transplant or who have switched to peritoneal dialysis;
Vascular access infections or active systemic infections;
Presence of other medical conditions considered ineligible for the study as assessed by the investigator.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

Emergency general hospital
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Tongren hospital, Capital medical university
Beijing, Beijing Municipality
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Shaoyifu hospital, zhejiang medical universiyt
Hangzhou, Zhejiang
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese
Shanghai, Shanghai Municipality, 200000
Huashan hospital affiliated to FuDan university
Shanghai, Shanghai Municipality
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Taiyuan Central Hospital
Taiyuan, Shanxi

Other trials in China

About this study

Official 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

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.

Read the detailed description

This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 220 subjects will be enrolled from 11 sites in China. All subjects enrolled will be randomly assigned to the test group (Dissolve AV group, n=110) and the control group (Armada 35 group, n=110) with randomized allocation ratio of 1:1. Subjects in the test group and the control group will be treated with Peripheral scoring drug balloon or Balloon Dilatation catheter

Conditions: Fistulas Arteriovenous
Being tested: Dissolve AVF, Armada 35
Keywords: Dialysis scoring Fistulas
Medical subject headings: Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dissolve AVFDevice
Also called Using Peripheral scoring drug balloon catheter to cover the whole treated segment
Subjects in the test group will be treated with peripheral scoring drug balloon.
Armada 35Device
Also called Using plain balloon catheter to cover the whole treated segment
Subjects in the test group will be treated with plain balloon catheter.

Study groups in NCT04226599
Study group	Role	What they receive
Dissolve AVF Group	Experimental	This group treated with Peripheral scoring drug balloon.Dissolve AVF Receives: Device: Dissolve AVF
PTA Group	Active comparator	This group treated with plain balloon catheter.Armada 35 Receives: Device: Armada 35

What is being measured

The primary outcome is the main question the study is designed to answer.

Target lesion primary patency (TLPP) at 6 months post-procedure
TLPP ends with postoperative target lesion (including 5 mm proximal and 5 mm distal to the target lesion) failure (TLF) or target lesion-associated vascular access thrombosis. TLF is defined as the presence of at least one clinical symptom of inadequate dialysis blood flow (as defined in the NKF-K/DOQI guidelines) due to stenosis of the target lesion (≥ 50% stenosis of the target lesion on imaging), including significantly elevated venous pressure during dialysis, abnormal physical examination findings, and a decrease in pump-controlled blood flow.
Measured: 6 month post-procedure

Secondary outcomes (4)

Target lesion primary patency (TLPP) at 12 months post-procedure
TLPP ends with postoperative target lesion (including 5 mm proximal and 5 mm distal to the target lesion) failure (TLF) or target lesion-associated vascular access thrombosis. TLF is defined as the presence of at least one clinical symptom of inadequate dialysis blood flow (as defined in the NKF-K/DOQI guidelines) due to stenosis of the target lesion (≥ 50% stenosis of the target lesion on imaging), including significantly elevated venous pressure during dialysis, abnormal physical examination findings, and a decrease in pump-controlled blood flow.
Measured: 12 Month post-procedure
Device success
When evaluated with a single balloon dilatation catheter, it is defined as successful reach of a target lesion, dilatation without rupture, and successful withdrawal.
Measured: 0 day post-procedure
Procedural Success
It is defined as ≤ 30% residual stenosis of the target lesion, and the absence of serious perioperative adverse events.
Measured: 0 day post-procedure
Clinical success
At least one session of successful hemodialysis following the procedure.
Measured: 0 - 5 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 20194 Jan 2022

First posted13 Jan 2020
Study start23 Jul 2019
Primary completion2 Oct 2021
Study completion4 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Fistulas ArteriovenousStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04226599
Sponsor's protocol ID: VP-P-2018-018
Acronym: DissolveAVF
Status last verified: Feb 2025
First submitted: 7 Jan 2020
Last updated: 11 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion

All Fistulas Arteriovenous trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04226599
Acronym / sponsor ID: DissolveAVF / VP-P-2018-018
Conditions: Fistulas Arteriovenous
Keywords: Dialysis scoring Fistulas
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: DK Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 23 Jul 2019 (actual)
Primary completion: 2 Oct 2021 (actual)
Study completion: 4 Jan 2022 (actual)
First posted: 13 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Dissolve AVF Group	Experimental	Device: Dissolve AVFThis group treated with Peripheral scoring drug balloon.Dissolve AVF
PTA Group	Active comparator	Device: Armada 35This group treated with plain balloon catheter.Armada 35

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 18-75 years (inclusive), male or female;
Patients with mature AVF/AVG and at least one successful hemodialysis session;
Target lesion located in the AVF/AVG reflux vein (excluding the feeding artery and central vein);
With hemodynamically significant AVF/AVG stenosis and meeting two of the following conditions (A \& B) A. ≥ 50% stenosis of the target lesion as assessed by angiography B. Presence of at least one of the following (as defined in the NKF-K/DOQI guidelines) 1)Significantly elevated venous pressure during dialysis 2)Unexplained decrease in dialysis dose 3)Decrease in pump-controlled blood flow;
De novo or restenotic target lesion consisting of one or more tandem lesions, and with a visual reference vessel diameter of 4.0-8.0 mm and a total length ≤ 40 mm for the target lesion;

Key exclusion criteria (18 listed)

Patients who are participating in another clinical trial of a drug product or medical device;
Patients previously enrolled in this trial;
Women of childbearing age with a non-negative pregnancy test prior to surgical procedure, or lactating women;
Patients treated with major surgeries (e.g., open-heart surgery, cranial surgery) within 30 days prior to enrollment in the study;
Immature AVF/AVG (not subjected to dialysis; this vascular access has not been subjected to a single successful dialysis due to insufficient inner diameter that prevents successful puncture and results in inadequate blood flow);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dissolve AVFAlso: Using Peripheral scoring drug balloon catheter to cover the whole treated segmentSubjects in the test group will be treated with peripheral scoring drug balloon.	Device	Dissolve AVF Group
Armada 35Also: Using plain balloon catheter to cover the whole treated segmentSubjects in the test group will be treated with plain balloon catheter.	Device	PTA Group

Primary outcome

Target lesion primary patency (TLPP) at 6 months post-procedure
Time frame: 6 month post-procedure
TLPP ends with postoperative target lesion (including 5 mm proximal and 5 mm distal to the target lesion) failure (TLF) or target lesion-associated vascular access thrombosis. TLF is defined as the presence of at least one clinical symptom of inadequate dialysis blood flow (as defined in the NKF-K/DOQI guidelines) due to stenosis of the target lesion (≥ 50% stenosis of the target lesion on imaging), including significantly elevated venous pressure during dialysis, abnormal physical examination findings, and a decrease in pump-controlled blood flow.

4 secondary outcomes

Target lesion primary patency (TLPP) at 12 months post-procedure
Time frame: 12 Month post-procedure
Device success
Time frame: 0 day post-procedure
Procedural Success
Time frame: 0 day post-procedure
Clinical success
Time frame: 0 - 5 days post-procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
Individual participant dataSharing planned: No

Related trials for Fistulas Arteriovenous

Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

YE CHAOYANG study chair

ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dissolve AVF and Armada 35 in people with Fistulas Arteriovenous, run by DK Medical Technology (Suzhou) Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion primary patency (TLPP) at 6 months post-procedure (time frame: 6 month post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04226599.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.