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

Femoral Artery Stenosis Clinical Trial

— DELTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608655
• Other study ID #: VP-P-22-005
• Status: Completed
• Phase: N/A
• Start date: December 27, 2022
• Est. completion date: February 4, 2024

Study information

• Verified date: February 2024
• Source: DK Medical Technology (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: February 4, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Femoral Artery Stenosis
• Popliteal Artery Stenosis

Intervention

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
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
DK Medical Technology (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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