| Trial Name | Trial ID | Link | News Report | Summary |
| DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA) | NCT05250193 | Read More | Read More | A prospective, multicenter, randomized controlled, open-label, non-inferiority study designed to evaluate immediate post-dilation lumen gain. The study will recruit 200 patients across four centers in China. All enrolled patients will be randomly assigned in a 1:1 ratio to either the experimental group (DK Score™ group, n=100) or the control group (NSE group, n=100). Patients in the experimental group will receive treatment with the DK Score™ scoring balloon catheter, while those in the control group will receive treatment with the NSE coronary dilation catheter. All 200 patients will undergo 30-day post-procedure follow-up. |
| A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV (DissolveAVF) | NCT04226599 | Read More | Read More | A prospective, multicenter, randomized controlled, open-label, superiority study designed to evaluate the safety and efficacy of the peripheral scoring drug-coated balloon (Dissolve AV) versus the balloon dilation catheter (Armada 35) for the treatment of arteriovenous fistula (AVF) stenosis in the Chinese population. The study will be conducted across 11 centers in China, enrolling a total of 220 subjects. All enrolled subjects will be randomly assigned in a 1:1 ratio to either the experimental group (Dissolve AV group, n=110) or the control group (Armada 35 group, n=110). Subjects in the experimental group will receive treatment with the peripheral scoring drug-coated balloon, while those in the control group will receive treatment with the balloon dilation catheter. |
| A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease | NCT03376646 | Read More | | A multicenter, randomized controlled study designed to evaluate the efficacy and safety of the drug-coated balloon (DCB) Dissolve™ compared to the drug-eluting stent (DES) Resolute™ Integrity in the treatment of coronary small vessel disease in the Chinese population. The study will be conducted across 15 centers in China, enrolling a total of 277 patients. |
| A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis | NCT03373695 | Read More | | A multicenter, randomized controlled study designed to evaluate the efficacy and safety of the paclitaxel-coated balloon catheter Dissolve™ compared to SeQuent® Please in the treatment of coronary in-stent restenosis (reference diameter of coronary stenosis is 2.5mm-4.0mm and length ≤26mm). The study will be conducted across 15 sites in China, enrolling a total of 260 patients. |
| DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis (DELTA) | NCT05608655 | Read More | Read More | A multicenter, prospective, randomized controlled trial designed to evaluate the efficacy and safety of the DKutting™ balloon compared to the Chocolate balloon in the treatment of femoral and popliteal artery stenosis. A total of 188 patients will be enrolled across 14 centers in China. All enrolled patients will be randomly assigned in a 1:1 ratio to either the experimental group (DKutting™ LL balloon group, n=94) or the control group (Chocolate balloon group, n=94). The primary endpoint is the proportion of cases achieving a diameter stenosis rate of <30% post-PTA without flow-limiting dissections. All 188 patients will undergo 30-day post-procedure follow-up. |
| Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis (DKTAVG) | NCT06503692 | Read More | Read More | This is a multicenter, prospective, randomized controlled clinical study that will recruit patients with stenosis of arteriovenous grafts used for hemodialysis. The aim is to explore whether scoring balloons are superior to high-pressure balloons in treating such lesions, thereby providing a basis for optimizing the treatment of these lesions. The study will be conducted at seven clinical trial sites, enrolling a total of 140 subjects. All enrolled patients will be randomly assigned in a 1:1 ratio to either the experimental group (DKutting™ scoring balloon dilation catheter) or the control group (peripheral balloon dilation catheter developed and manufactured by DK Medtech). Clinical follow-ups will be conducted at 5 days, 3 months, 6 months, and 12 months post-surgery. |
| Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis (SCDB) | NCT06422845 | Read More | | This is a prospective, multicenter, single-arm, target-value clinical study designed to evaluate the safety and efficacy of the peripheral scoring drug-coated balloon catheter in the treatment of stenosis in arteriovenous fistulas for hemodialysis. A total of 328 subjects will be enrolled across 33 centers. Subjects will undergo surgical treatment using the peripheral scoring drug-coated balloon catheter and will be followed up at 5 days, 1 month, 6 months, 12 months, 18 months, and 24 months post-surgery. The target lesion primary patency rate (TLPP) at 6 months post-surgery is defined as the primary endpoint for evaluating the safety and efficacy of the peripheral scoring drug-coated balloon catheter. |
