DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis
- Conditions
- Popliteal Artery StenosisFemoral Artery Stenosis
- Interventions
- Device: DKutting LL balloonDevice: Chocolate balloon
- Registration Number
- NCT05608655
- Lead Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DKutting DKutting LL balloon DKutting LL Scoring Balloon, DK Medtech Co Ltd Chocolate Chocolate balloon Chocolate Balloon, TriReme Medical LLC
- Primary Outcome Measures
Name Time Method Achievement of Optimal PTA in Percent 1 day 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. \[0-100%, higher the better\]
- Secondary Outcome Measures
Name Time Method Device Success Rate in Percent 1 day Device Success defined as successful delivery to the target lesion, deployment without balloon rupture, and retrieval after procedure, as qualitatively accessed by physician. \[0-100%, higher the better\]
Numerical Ankle Brachial Index 0-7days Record of both groups' patient's Ankle Brachial Index (ABI) pre/post procedure by Doppler ultrasonic stethoscope. \[ABI≤0.9: confirmed peripheral artery disease; ABI≥0.97: normal people\]
Freedom from clinical-driven TLR rate in percent 30+/-7 Days post procedure Freedom from clinical-driven target lesion revascularization 1 month post procedure \[0-100%, higher the better\]
Rutherford Grading Reduction in percent 30+/-7 Days post procedure 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. \[0-100%, higher the better\]
Freedom from Amputation above ankle rate in percent 30+/-7 Days post procedure Percentage of both groups' patient number who is free from Amputation above ankle 1 month post procedure. \[0-100%, higher the better\]
Numerical Acute Lumen Gain in mm 1 day 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. \[0-3mm, higher the better\]
Technical Success Rate in percent 0-7 days Percentage of target Lesion achieved \<30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F) and No Adverse Event happened in hospital. \[0-100%, higher the better\]
Trial Locations
- Locations (14)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Hospital of Chengdu Traditional Chinese Medicine University
🇨🇳Chengdu, Sichuan, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
The Third People's Hospital of Chengdu
🇨🇳Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
🇨🇳Luzhou, Sichuan, China
The First Affiliated Hospital of Naval Medical University
🇨🇳Shanghai, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
Xuanwu Hospital of Capital Medical University
🇨🇳Beijing, China
Zhongshan Hospital of Fudan University
🇨🇳Shanghai, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China