DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis

NCT05608655 | Completed DMC

• 1 other identifier: VP-P-22-005
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 14

Brief Summary

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis

Conditions

Femoral Artery Stenosis; Popliteal Artery Stenosis

Keywords

PTA Scoring Balloon; Optimal Balloon Angioplasty

Outcome Measures

Primary Outcomes (1)

• Achievement of Optimal PTA in Percent

  Percentage of PTA cases in which \<30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F). Residual stenosis in percent and dissection NHLBI grading are accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. \[0-100%, higher the better\]

  1 day

Secondary Outcomes (7)

• Device Success Rate in Percent

  1 day

• Numerical Acute Lumen Gain in mm

  1 day

• Technical Success Rate in percent

  0-7 days

• Freedom from clinical-driven TLR rate in percent

  30+/-7 Days post procedure

• Rutherford Grading Reduction in percent

  30+/-7 Days post procedure

Study Arms (2)

DKutting

EXPERIMENTAL

DKutting LL Scoring Balloon, DK Medtech Co Ltd

Device: DKutting LL balloon

Chocolate

ACTIVE COMPARATOR

Chocolate Balloon, TriReme Medical LLC

Device: Chocolate balloon

Interventions

DKutting LL balloon DEVICE

After pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment

DKutting

Chocolate balloon DEVICE

After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment

Chocolate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year-old male \& non-pregnant female
• Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery.
• Rutherford clinical category-Becker class: 2 to 5
• Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.
• Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty
• Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mm
• Only one target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3.

You may not qualify if:

• Acute or sub-acute thrombosis exist in target lesion
• Severe calcified lesion (PACSS Grading 4)
• Guidewire cannot cross target lesion
• Amputation planned within 30 days
• In-stent restenosis
• Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilation
• No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk, ELCA etc.) are treated before or after test/control group treatment.
• Before test/control group treatment, target lesion was expanded by Antegrade Dissection Re-entry (ADR) technique.
• Patient who cannot accept anticoagulant or antiplatelet therapy
• Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics
• Patients who have not completed clinical trials of other drugs or devices
• Patients with poor compliance and unable to complete the study, which is identified by investigator.

Sponsors & Collaborators

• DK Medical Technology (Suzhou) Co., Ltd.: lead

Study Sites (14)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Hospital of Chengdu Traditional Chinese Medicine University

Chengdu, Sichuan, China

Location

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

Xuanwu Hospital of Capital Medical University

Beijing, China

Location

The First Affiliated Hospital of Naval Medical University

Shanghai, China

Location

Zhongshan Hospital of Fudan University

Shanghai, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

Study Officials

• Weiguo Fu, Dr.

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 8, 2022
• Study Start: December 27, 2022
• Primary Completion: January 10, 2024
• Study Completion: February 4, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CN (14)