A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962141
• Other study ID #: APERTO-2015-01
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: ZhuHai Cardionovum Medical Device Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
Treatment group
• Balloon Dilatation Catheter
Control group

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, Capital Medical University	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Hainan General Hospital	Haikou	Hainan
China	Sir Run Run Shaw Hospital School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The First Hospital of Zhejiang Province	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Longhua Hospital Shanghai University of Tranditional Chinese Medicine	Shanghai
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
ZhuHai Cardionovum Medical Device Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency rate of the target lesion	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.	at 6 month post procedure
Secondary	Device Success	Device Success is defined as ability of the Device to be delivered, inflated at pressure = RBP, and retrieved from the Target Lesion without burst.	intraoperative
Secondary	Technical Success	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).	intraoperative
Secondary	Clinical Success	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.	at 1 month
Secondary	Procedural Success	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)	at 1 month
Secondary	MAE rates (death or stroke)		at 1 month, 3 months, 6 months, and 12 months post procedure.
Secondary	The diameter stenosis rate in target lesion	The diameter stenosis (%)=100% × (1-(MLD/RVD))	at 6 months post procedure
Secondary	Clinical-driven Target Lesion Revascularization (CD-TLR)	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.	in1st, 3rd, 6th, 12th month post operation
Secondary	Clinical-driven Target Shunt Revascularization (CD-TSR)	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.	in 1st, 3rd, 6th, 12th month post operation