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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05608655
Other study ID # VP-P-22-005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
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Completed NCT01412541 - Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries N/A
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Active, not recruiting NCT05734157 - CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery N/A
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Terminated NCT02813577 - Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM) N/A
Completed NCT03844724 - Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion N/A
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A