## Protocol Section
### Identification Module
**NCT ID:** NCT06422845

**Acronym:** SCDB

**Brief Title:** Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

**Official Title:** A Prospective, Multicenter, Single-Arm Target Value Clinical Study to Evaluate the Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

#### Organization Study ID Info
**ID:** VP-P-24-012
#### Organization
**Class:** INDUSTRY
**Full Name:** DK Medical Technology (Suzhou) Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** DK Medical Technology (Suzhou) Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Arteriovenous Fistula Stenosis

**Keywords:**

- arteriovenous fistula stenosis

- scoring

- hemodialysis

- drug-coated balloon

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 328

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects in this group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter

**Intervention Names:**

- Device: Dissolve AV Peripheral Scoring Drug-coated Balloon

**Label:** Dissolve AV Peripheral Scoring Drug-coated Balloon

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dissolve AV Peripheral Scoring Drug-coated Balloon

**Description:** Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon

**Name:** Dissolve AV Peripheral Scoring Drug-coated Balloon

**Other Names:**

- Scoring Drug-coated Balloon

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Target Lesion Primary Patency (TLPP) at 6 months post-procedure

**Time Frame:** 6 months post-procedure

#### Secondary Outcomes

**Description:** 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.

**Measure:** Target Lesion Primary Patency (TLPP)

**Time Frame:** 12, 24 months post-procedure

**Description:** 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.

**Measure:** 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

**Time Frame:** 6, 12, 24 months post-procedure

**Description:** 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.

**Measure:** Clinically-driven Target Lesion Revascularization (CD-TLR)

**Time Frame:** 1, 6, 12, 18, and 24 months post-procedure

**Measure:** Clinically-driven Target Shunt Revascularization (CD-TSR)

**Time Frame:** 1, 6, 12, 18, and 24 months post-procedure

**Description:** 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.

**Measure:** Device Success

**Time Frame:** During the procedure

**Description:** 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.

**Measure:** Technical Success

**Time Frame:** 0-5 days post-procedure

**Description:** Defined as ability to complete at least one successful hemodialysis session post-procedure.

**Measure:** Clinical Success

**Time Frame:** 0-5 days post-procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years old;
2. The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
3. The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
4. Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up visit, etc.;
5. The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion);
6. Visual inspection of the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤ 60mm;
7. The patient voluntarily signs the informed consent form.

Exclusion Criteria:

1. Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
2. Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
3. Calcified lesions that are not expected to be expandable with balloons;
4. Patients with thrombosis at the access stenosis site;
5. The target lesion is located at the blood supply artery and arterial anastomosis;
6. Patients known to be allergic to or intolerant to contrast media and paclitaxel;
7. The patient's life expectancy is less than 2 years;
8. Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis;
9. Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis;
10. Vascular access infection or systemic active infection;
11. Those who have participated in unfinished clinical trials of other drugs or devices;
12. Patients with other medical conditions that the investigator believes are not suitable to participate in this study.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wyz4417@126.com

**Name:** Yuzhu Wang, MD

**Phone:** 18701387950

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hefei

**Contacts:**

***Contact 1:***

- **Name:** Liang Yuan

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Hospital of Anhui Medical University

**State:** Anhui

**Location 2:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** wyz4417@126.com

- **Name:** Yuzhu Wang, MD

- **Phone:** 18701387950

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Haidian Hospital

**State:** Beijing

**Location 3:**

**City:** Chongqing

**Contacts:**

***Contact 1:***

- **Name:** Qining Fu

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Chongqing Medical University

**State:** Chongqing

**Location 4:**

**City:** Guanzhou

**Contacts:**

***Contact 1:***

- **Name:** Riguang Liu

- **Role:** CONTACT

**Country:** China

**Facility:** Guangzhou First People's Hospital

**State:** Guangdong

**Location 5:**

**City:** Huizhou

**Contacts:**

***Contact 1:***

- **Name:** Qiming Chen

- **Role:** CONTACT

**Country:** China

**Facility:** Huizhou Central People's Hospital

**State:** Guangdong

**Location 6:**

**City:** Shenzhen

**Contacts:**

***Contact 1:***

- **Name:** Wei Liang

- **Role:** CONTACT

**Country:** China

**Facility:** Peking University Shenzhen Hospital

**State:** Guangdong

**Location 7:**

**City:** Shenzhen

**Contacts:**

***Contact 1:***

- **Name:** Tiecheng Yang

- **Role:** CONTACT

**Country:** China

**Facility:** The Eighth Affiliated Hospital, Sun Yat-sen University

**State:** Guangdong

**Location 8:**

**City:** Liuzhou

**Contacts:**

***Contact 1:***

- **Name:** Yuhong Chen

- **Role:** CONTACT

**Country:** China

**Facility:** Liuzhou Traditional Chinese Medical Hospital

**State:** Guangxi

**Location 9:**

**City:** Nanning

**Contacts:**

***Contact 1:***

- **Name:** Xiaomei Peng

- **Role:** CONTACT

**Country:** China

**Facility:** Foresea Life Insurance Guangxi Hospital

**State:** Guangxi

**Location 10:**

**City:** Guiyang

**Contacts:**

***Contact 1:***

- **Name:** Zongyang Liu

- **Role:** CONTACT

**Country:** China

**Facility:** The Affiliated Cancer Hospital of Guizhou Medical University

**State:** Guizhou

**Location 11:**

**City:** Zhengzhou

**Contacts:**

***Contact 1:***

- **Name:** Hongtao Zhang

- **Role:** CONTACT

**Country:** China

**Facility:** Henan Provincial People's Hospital

**State:** Henan

**Location 12:**

**City:** Wuhan

**Contacts:**

***Contact 1:***

- **Name:** Fan He

- **Role:** CONTACT

**Country:** China

**Facility:** Tongji Hospital Affiliated To Tongji Medical College HUST

**State:** Hubei

**Location 13:**

**City:** Changsha

**Contacts:**

***Contact 1:***

- **Name:** Yong Xu

- **Role:** CONTACT

**Country:** China

**Facility:** Changsha Jieao Kidney Disease Hospital

**State:** Hunan

**Location 14:**

**City:** Changsha

**Contacts:**

***Contact 1:***

- **Name:** Xun Luo

- **Role:** CONTACT

**Country:** China

**Facility:** Hunan Provincial People's Hospital

**State:** Hunan

**Location 15:**

**City:** Changsha

**Contacts:**

***Contact 1:***

- **Name:** Hong Wu

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Xiangya Hospital of Central South University

**State:** Hunan

**Location 16:**

**City:** Nanchang

**Contacts:**

***Contact 1:***

- **Name:** Yan Yan

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Nanchang University

**State:** Jiangxi

**Location 17:**

**City:** Changchun

**Contacts:**

***Contact 1:***

- **Name:** Mingxin Chang

- **Role:** CONTACT

**Country:** China

**Facility:** The Affiliated Hospital To Changchun University of Chinese Medicine

**State:** Jilin

**Location 18:**

**City:** Xi'an

**Contacts:**

***Contact 1:***

- **Name:** Shifeng Yang

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Xi'an Jiaotong University

**State:** Shaanxi

**Location 19:**

**City:** Dezhou

**Contacts:**

***Contact 1:***

- **Name:** Jing Sun

- **Role:** CONTACT

**Country:** China

**Facility:** Qilu Hospital of Shandong University Dezhou Hospital

**State:** Shandong

**Location 20:**

**City:** Jinan

**Contacts:**

***Contact 1:***

- **Name:** Xiaoping Wang

- **Role:** CONTACT

**Country:** China

**Facility:** Central Hospital Affiliated To Shandong First Medical University

**State:** Shandong

**Location 21:**

**City:** Jinan

**Contacts:**

***Contact 1:***

- **Name:** Zunsong Wang

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Shandong First Medical University

**State:** Shandong

**Location 22:**

**City:** Qingdao

**Contacts:**

***Contact 1:***

- **Name:** Jian Sun

- **Role:** CONTACT

**Country:** China

**Facility:** Qingdao Municipal Hospital

**State:** Shandong

**Location 23:**

**City:** Rizhao

**Contacts:**

***Contact 1:***

- **Name:** Hong Zhang

- **Role:** CONTACT

**Country:** China

**Facility:** People's Hospital of Rizhao

**State:** Shandong

**Location 24:**

**City:** Taiyuan

**Contacts:**

***Contact 1:***

- **Name:** Hua Chen

- **Role:** CONTACT

**Country:** China

**Facility:** Shanxi Bethune Hospital

**State:** Shanxi

**Location 25:**

**City:** Chengdu

**Contacts:**

***Contact 1:***

- **Name:** Qiang He

- **Role:** CONTACT

**Country:** China

**Facility:** Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital

**State:** Sichuan

**Location 26:**

**City:** Chengdu

**Contacts:**

***Contact 1:***

- **Name:** Ping Fu

- **Role:** CONTACT

**Country:** China

**Facility:** West China Hospital Sichuan University

**State:** Sichuan

**Location 27:**

**City:** Mianyang

**Contacts:**

***Contact 1:***

- **Name:** Dan Liao

- **Role:** CONTACT

**Country:** China

**Facility:** Mianyang Central Hospital

**State:** Sichuan

**Location 28:**

**City:** Nanchong

**Contacts:**

***Contact 1:***

- **Name:** Heping Zhang

- **Role:** CONTACT

**Country:** China

**Facility:** Affiliated Hospital of North Sichuan Medical College

**State:** Sichuan

**Location 29:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Name:** Hua Li

- **Role:** CONTACT

**Country:** China

**Facility:** Sir Run Run Shaw Hospital Zhejiang University School of medicine

**State:** Zhejiang

**Location 30:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Name:** Hua Jiang

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital, Zhejiang University School of Medicine

**State:** Zhejiang

**Location 31:**

**City:** Jinhua

**Contacts:**

***Contact 1:***

- **Name:** Yangbiao He

- **Role:** CONTACT

**Country:** China

**Facility:** Jinhua Hospital of TCM

**State:** Zhejiang

**Location 32:**

**City:** Taizhou

**Contacts:**

***Contact 1:***

- **Name:** Liyun Xu

- **Role:** CONTACT

**Country:** China

**Facility:** Taizhou Hospital of Zhejiang Province

**State:** Zhejiang

**Location 33:**

**City:** Ürümqi

**Contacts:**

***Contact 1:***

- **Name:** Alpati

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Xinjiang Medical University

**State:** Ürümqi

#### Overall Officials

**Official 1:**

**Affiliation:** Beijing Haidian Hospital

**Name:** Yuzhu Wang, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000001165

- Term: Arteriovenous Malformations

- ID: D000054079

- Term: Vascular Malformations

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016157

- Term: Vascular Fistula

- ID: D000014652

- Term: Vascular Diseases

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M8532

- Name: Fistula

- Relevance: HIGH

- As Found: Fistula

- ID: M4472

- Name: Arteriovenous Fistula

- Relevance: HIGH

- As Found: Arteriovenous Fistula

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: HIGH

- As Found: Stenosis

- ID: M7292

- Name: Dilatation, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M4473

- Name: Arteriovenous Malformations

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M27558

- Name: Vascular Malformations

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M18619

- Name: Vascular Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001164

- Term: Arteriovenous Fistula

- ID: D000003251

- Term: Constriction, Pathologic

- ID: D000005402

- Term: Fistula

### Misc Info Module

- Version Holder: 2024-05-31
