A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO

• ClinicalTrials.gov Identifier: NCT02962141
• Recruitment Status: Completed
• First Posted: November 11, 2016
• Last Update Posted: August 7, 2019
• Sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.
• Information provided by (Responsible Party): ZhuHai Cardionovum Medical Device Co., Ltd.

Study Description

Brief Summary:

To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease; Fistula	Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter; Device: Balloon Dilatation Catheter	Not Applicable

Detailed Description:

To evaluate the safety and efficacy of the Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.

This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 160 subjects will be enrolled from 10 sites in China. All subjects enrolled will be randomly assigned to the test group (APERTO group, n=80) and the control group (OHICHO II group, n=80) with randomized allocation ratio of 1:1. Subjects in the test group and the control group will be treated with APERTO OTW or OHICHO II respectively.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 161 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety and Efficacy of the Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) in Treatment of Hemodialysis Arteriovenous Fistulae Stenosis: A Prospective, Multicenter, Randomized, Controlled Clinical Study
• Study Start Date: October 2016
• Actual Primary Completion Date: January 2018
• Actual Study Completion Date: June 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: APERTO OTW group; in the APERTO OTW group the subject will be treated with APERTO OTW balloon (Paclitaxel Releasing Peripheral Balloon Dilatation Catheter)	Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter; Treatment group; Other Name: APERTO OTW
Active Comparator: OHICHO II group; in the OHICHO II group the subject will be treated with OHICHO II balloon (Balloon Dilatation Catheter)	Device: Balloon Dilatation Catheter; Control group; Other Name: OHICHO II

Outcome Measures

Primary Outcome Measures :

1. Primary patency rate of the target lesion [ Time Frame: at 6 month post procedure ]

   Primary patency is defined as freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.0 and freedom from clinically-driven target lesion revascularization (CD-TLR).

   Restenosis is defined as PSVR> 2.0 determined by independent DUS laboratory. Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention in target lesion (+/-5mm proximal or distal of the target lesion) determined by DUS due to clinical symptoms or dialysis indicators showing that it is unable to perform dialysis.

Secondary Outcome Measures :

1. Device Success [ Time Frame: intraoperative ]
   Device Success is defined as ability of the Device to be delivered, inflated at pressure ≤ RBP, and retrieved from the Target Lesion without burst.
2. Technical Success [ Time Frame: intraoperative ]
   Technical Success is defined as the residual stenosis of the lumen diameter ≤ 30% after treatment with either APERTO OTW or OHICHO II (compared with the referred vessel diameter of the nearest veins with no aneurysm).
3. Clinical Success [ Time Frame: at 1 month ]
   Clinical Success is defined as improvement in hemodialysis access function and resumption of normal dialysis for at least one dialysis session after the index procedure.
4. Procedural Success [ Time Frame: at 1 month ]
   Procedural Success is defined as technical success without the occurrence of MAE during the hospitalization or day of treatment (MAE defined here as: death, stroke, thrombotic occlusion, allergic reaction, pulmonary events (including pulmonary edema)
5. MAE rates (death or stroke) [ Time Frame: at 1 month, 3 months, 6 months, and 12 months post procedure. ]
6. The diameter stenosis rate in target lesion [ Time Frame: at 6 months post procedure ]
   The diameter stenosis (%)=100% × (1-(MLD/RVD))
7. Clinical-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: in1st, 3rd, 6th, 12th month post operation ]
   CD-TLR is defined as any re-intervention in target lesion (+/-5mm proximal or distal of the target lesion) determined by DUS due to clinical symptoms or dialysis indicators showing that it is unable to perform dialysis.
8. Clinical-driven Target Shunt Revascularization (CD-TSR) [ Time Frame: in 1st, 3rd, 6th, 12th month post operation ]

   Target Shunt is defined as the reflux vein, which is from the anastomotic stoma of native arteriovenous fistula (AVF) to the distal end of the subclavian vein.

   CD-TSR is defined as any re-intervention in target lesion due to clinical symptoms or inability to perform dialysis.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria:

Patients must meet all of the following criteria:

• Age ≥ 18 years and ≤ 75 years, male or female.
• Patient or legally authorized representative can understand the purpose of this clinic trial. He or She volunteers to participate in this trial and can provide written informed consent, and is willing to accept the scheduled follow-up in specific time points.
• Angiography, ultrasound or clinical diagnosis shows that patients have hemodialysis access dysfunction due to stenosis lesions.

• Patients with indications of the percutaneous endovascular therapy, that is, the AVF stenosis is related to hemodynamics and ≥ 50%, and with any of the following clinical and physiological abnormalities (referred to NKF-K/DOQI guideline definitions):

  1. Thrombosis in the AVF;
  2. Elevated venous pressure during dialysis
  3. Obvious abnormality in recirculation measurements
  4. Abnormal physical examination findings
  5. Unexplained decreases in dialysis dose
  6. Decreased access flow
• Target lesion is a de novo or restenosis. The number of target lesions is 1.
• Target lesion consists of a single lesion or a multiple lesions with target lesion length ≤ 40 mm.
• Target lesion(s) is located in the reflux vein which is from the anastomosis of native arteriovenous fistula (AVF) to the distal end of subclavian vein, except the anastomosis of native AVF.
• If patient has non-target lesion, it must be successfully treated using PTA before treating target lesion.
• Reference vessel diameter of target lesion ≥ 4.0 mm and ≤ 7.0 mm by visual estimate (determined by angiography or DUS).
• Hemodialysis access previously used (mature AVF) can no longer be successfully used due to insufficient shunt flow volume caused by local lumen stenosis.

Exclusion criteria:

Patients will be excluded if any of the following conditions applies:

• Patients who have participated in another investigational drug or device trial.
• Patients who have been enrolled in this trial previously.
• Women of childbearing age with negative pregnancy test before procedure, and breastfeeding women.
• Any major surgical procedure (such as thoracotomy, craniotomy, etc.) within 30 days prior to the procedure.
• Any planned major surgical procedure (such as thoracotomy, craniotomy, etc.) within 30 days of entry into this study
• Immature AVF, which cannot be used for Dialysis or has not been used successfully due to insufficient lumen diameter to ensure successfully puncture and insufficient shunt flow volume.
• Patients with AVG.
• AVF has been previously implanted with stent.
• Lesion in AVF has been previously treated with DEB.
• Target lesion is located in the anastomosis of native AVF.
• Known allergies or intolerance to Paclitaxel or contrast medium.
• Life expectancy < 1 year
• Patients with comitans systemic lupus erythematosus and ANCA associated vasculitis.

Contacts and Locations

Locations

China, Hainan

Hainan General Hospital

Haikou, Hainan, China

China, Hebei

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

China, Hunan

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

China, Jiangxi

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

China, Sichuan

West China Hospital, Sichuan University

Chengdu, Sichuan, China

China, Zhejiang

Sir Run Run Shaw Hospital School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

The First Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Longhua Hospital Shanghai University of Tranditional Chinese Medicine

Shanghai, China

Sponsors and Collaborators

ZhuHai Cardionovum Medical Device Co., Ltd.

Investigators

• Principal Investigator: Qizhuang Jin, professor; Peking University First Hospital

More Information

• Responsible Party: ZhuHai Cardionovum Medical Device Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02962141
• Other Study ID Numbers: APERTO-2015-01
• First Posted: November 11, 2016
• Last Update Posted: August 7, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by ZhuHai Cardionovum Medical Device Co., Ltd.:

drug eluting balloon, Arteriovenous Fistulae

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Arteriovenous Fistula; Fistula; Pathological Conditions, Anatomical; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Vascular Fistula; Congenital Abnormalities; Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action