A prospective, Multi-center, Randomized Study designed to evaluate the acute lumen gain and device procedural success of the DK ScoreTM Scoring balloon versus NSE Scoring Balloon for patients with coronary arteries stenosis.
This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate Acute Lumen Gain after dilatation. A total of 200 patients will be enrolled from 4 sites in China. All patients enrolled will be randomly assigned to the test group (DK ScoreTM group, n=100) and the control group (NSE group, n=100) with randomized allocation ratio of 1:1. Patients in the test group and the control group will be treated with DK ScoreTM Scoring balloon catheters or NSE Coronary Dilatation Catheter. A 30-day after procedure follow-up will be conducted for all 200 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
After pre-dilation balloon is used (if any), DK Score is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment.
After pre-dilation balloon is used (if any), NSE is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment.
Beijing Anzhen Hospital affiliated to Capital University of Medical
Beijing, Beijing Municipality, China
Xuzhou Third People Hospital
Xuzhou, Jiangsu, China
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Tianjin Chest Hospita
Tianjin, Tianjin Municipality, China
Numerical Acute Lumen Gain in mm (QCA)
Acute Lumen Gain for both arms will be measure with QCA, as accessed by independent core-lab. Angiographic endpoint will be in-lesion acute lumen gain defined as minimal lumen diameter (MLD) in lumen after dilatation by either arm device minus baseline MLD.
Time frame: During the procedure
Rate of Device success in percent
Successful delivery to the target lesion, deployment, achieving less than 50% residual stenosis, and retrieval after procedure.
Time frame: During the procedure
Rate of Target Lesion Failure in percent
Defined as any Target Lesion Failure after procedure
Time frame: 30±7 Days
Rate of Patient-oriented Composite Endpoint (POCE) in percent
Patient-oriented Composite Endpoint after procedure
Time frame: 30±7 Days
Rate of other Complications in percent
Incidence of complications associated with the use of scoring balloon catheters
Time frame: During the procedure
Rate of Clinical Success in percent
Defined as \<20% diameter stenosis after stenting for DCB, without in-hospital major adverse cardiac events/MI/TLR After PCI
Time frame: During the procedure
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