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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
188
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
After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
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. \[0-100%, higher the better\]
Time frame: 1 day
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. \[0-100%, higher the better\]
Time frame: 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. \[0-3mm, higher the better\]
Time frame: 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. \[0-100%, higher the better\]
Time frame: 0-7 days
Freedom from clinical-driven TLR rate in percent
Freedom from clinical-driven target lesion revascularization 1 month post procedure \[0-100%, higher the better\]
Time frame: 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. \[0-100%, higher the better\]
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Zhengzhou, Henan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Hospital of Chengdu Traditional Chinese Medicine University
Chengdu, Sichuan, China
The Third People's Hospital of Chengdu
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
China-Japan Friendship Hospital
Beijing, China
...and 4 more locations
Time frame: 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. \[0-100%, higher the better\]
Time frame: 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. \[ABI≤0.9: confirmed peripheral artery disease; ABI≥0.97: normal people\]
Time frame: 0-7days