DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis (DELTA)

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

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

Study Overview

• Status: Completed
• Conditions: Popliteal Artery Stenosis; Femoral Artery Stenosis
• Intervention / Treatment: Device: DKutting LL balloon; Device: Chocolate balloon

Detailed Description

This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate achievement of optimal PTA dilatation. A total of 188 patients will be enrolled from 14 sites in China. All patients enrolled will be assigned to the test group (DKutting LL balloon, n=94) and the control group (Chocolate balloon, n=94) with randomized allocation ratio of 1:1.

Primary endpoint is percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • China-Japan Friendship Hospital
  • Beijing, China
    • Xuanwu Hospital of Capital Medical University
  • Shanghai, China
    • Zhongshan Hospital of Fudan University
  • Shanghai, China
    • The First Affiliated Hospital of Naval Medical University
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Jinan University
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China
      • The First Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital of Central South University
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Suzhou Municipal Hospital
  • Shandong
    • Qingdao, Shandong, China
      • The Affiliated Hospital Of Qingdao University
  • Sichuan
    • Chengdu, Sichuan, China
      • Hospital of Chengdu Traditional Chinese Medicine University
    • Chengdu, Sichuan, China
      • The Third People's Hospital of Chengdu
    • Luzhou, Sichuan, China
      • The Affiliated Hospital of Southwest Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-80 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DKutting; DKutting LL Scoring Balloon, DK Medtech Co Ltd	Device: DKutting LL balloon; 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
Active Comparator: Chocolate; Chocolate Balloon, TriReme Medical LLC	Device: Chocolate balloon; After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success Rate in Percent	Device Success defined as successful delivery to the target lesion, deployment without balloon rupture, and retrieval after procedure, as qualitatively accessed by physician. [0-100%, higher the better]	1 day
Numerical Acute Lumen Gain in mm	In-lesion acute lumen gain defined as minimal lumen diameter (MLD) in lumen after dilatation by either arm device minus baseline MLD, as accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-3mm, higher the better]	1 day
Technical Success Rate in percent	Percentage of target Lesion achieved <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F) and No Adverse Event happened in hospital. [0-100%, higher the better]	0-7 days
Freedom from clinical-driven TLR rate in percent	Freedom from clinical-driven target lesion revascularization 1 month post procedure [0-100%, higher the better]	30+/-7 Days post procedure
Rutherford Grading Reduction in percent	Percentage of both groups' patent number, whose Rutherford Grading [0-6, lower is reduced by at least 1 grade post procedure, compared with pre-procedure grade. [0-100%, higher the better]	30+/-7 Days post procedure
Freedom from Amputation above ankle rate in percent	Percentage of both groups' patient number who is free from Amputation above ankle 1 month post procedure. [0-100%, higher the better]	30+/-7 Days post procedure
Numerical Ankle Brachial Index	Record of both groups' patient's Ankle Brachial Index (ABI) pre/post procedure by Doppler ultrasonic stethoscope. [ABI≤0.9: confirmed peripheral artery disease; ABI≥0.97: normal people]	0-7days

Collaborators and Investigators

• Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
• Investigators: Principal Investigator: Weiguo Fu, Dr., Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2022
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): February 4, 2024

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PTA Scoring Balloon; Optimal Balloon Angioplasty
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: VP-P-22-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No