A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO
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|ClinicalTrials.gov Identifier: NCT02962141|
Recruitment Status : Active, not recruiting
First Posted : November 11, 2016
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Fistula||Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter Device: Balloon Dilatation Catheter||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Completion Date :||April 2019|
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
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
Other Name: OHICHO II
- 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.
- 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.
- 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).
- 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.
- 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)
- MAE rates (death or stroke) [ Time Frame: at 1 month, 3 months, 6 months, and 12 months post procedure. ]
- The diameter stenosis rate in target lesion [ Time Frame: at 6 months post procedure ]The diameter stenosis (%)=100% × (1-(MLD/RVD))
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962141
|Hainan General Hospital|
|Haikou, Hainan, China|
|The First Hospital of Hebei Medical University|
|Shijiazhuang, Hebei, China|
|The Third Xiangya Hospital of Central South University|
|Changsha, Hunan, China|
|The First Affiliated Hospital of Nanchang University|
|Nanchang, Jiangxi, China|
|West China Hospital, Sichuan University|
|Chengdu, Sichuan, China|
|Sir Run Run Shaw Hospital School of Medicine, Zhejiang University|
|Hangzhou, Zhejiang, China|
|The First Hospital of Zhejiang Province|
|Hangzhou, Zhejiang, China|
|Beijing Tongren Hospital, Capital Medical University|
|Longhua Hospital Shanghai University of Tranditional Chinese Medicine|
|Principal Investigator:||Qizhuang Jin, professor||Peking University First Hospital|