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August 26, 2026
DASBAD-NC Trial Will Evaluate DK Medtech’s NC Directional Scoring Balloon in CLTI
KEY TAKEAWAYS
- DASBAD-NC will compare DK Medtech’s directional scoring balloon technology with standard noncompliant balloon vessel preparation in patients with CLTI.
- The prospective, randomized, multicenter study is expected to enroll 142 patients with femoropopliteal lesions, anticipated to begin in Q4 2026.
- The trial’s principal investigator is Marc Sirvent, MD, from Hospital General de Granollers in Granollers, Spain.
August 26, 2026—DK Medical Technology Co., Ltd. (DK Medtech), a China-based developer of interventional balloon technologies, announced a clinical research partnership with principal investigator Marc Sirvent, MD, and co-investigator Marco Manzi, MD, on the newly registered DASBAD-NC clinical trial. Dr. Sirvent is from Hospital General de Granollers in Granollers, Spain. Dr. Manzi is from Abano Terme, Italy.
According to DK Medtech, the prospective, randomized, multicenter study will evaluate noncompliant directional scoring balloon technology versus standard noncompliant balloon vessel preparation to treat chronic limb-threatening ischemia (CLTI). The study will enroll 142 patients with real-world femoropopliteal lesions.
The company’s DKutting percutaneous transluminal angioplasty (PTA) scoring balloon dilatation catheter and DKutting long lesion (LL) peripheral scoring balloon dilatation catheter will serve as the vessel preparation platform in the study’s treatment arm.
Ethics committee submissions for the DASBAD-NC trial are scheduled for completion in September 2026. The first-patient enrollment is anticipated in the fourth quarter of 2026, advised DK Medtech.
The company stated that the investigator-initiated DASBAD-NC trial builds on the published outcomes of the original DASBAD randomized controlled trial, which demonstrated that scoring balloon vessel preparation before drug-coated balloon angioplasty reduced bailout stenting, improved primary patency, and lowered procedural costs in CLTI patients with femoropopliteal lesions.
Results from the DASBAD trial were recently published online by Dr. Sirvent et al in the European Journal of Vascular & Endovascular Surgery.
“DASBAD proved the value of scoring balloons for vessel preparation in CLTI patients,” commented Dr. Sirvent in the company’s press release. “With DASBAD-NC, we are advancing that evidence in a multicenter setting using DK Medtech’s unique noncompliant, directional scoring technology. This trial will help define standardized, reproducible vessel preparation strategies to improve long-term patency and outcomes for our patients.”
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