Clinical efficacy and safety of the Jetstream Atherectomy System in Chinese Patients with femoropopliteal artery occlusive disease

Abstract

Abstract Purpose This prospective, multicenter, single-arm clinical trial evaluated the safety and efficacy of the Jetstream Atherectomy System in 72 Chinese patients with calcified femoropopliteal artery occlusive disease (FPOAD). Materials and methods The study protocol was approved by the institutional review boards of all participating centers, and all participants provided written informed consent. The primary endpoints were 30-day major adverse events (MAE) and changes in angiographic stenosis. Secondary endpoints included vessel patency, clinical improvement, and adverse events during follow-up. Results The study cohort had a mean age of 67.5 ± 9.0 years, with a high prevalence of hypertension (79.2%) and diabetes (37.5%). Severe calcification (PACSS, Peripheral Arterial Calcium Scoring System, grade 3–4) was present in 43.1% of lesions. Technical success (≤ 30% residual stenosis) was achieved in 91.7% of cases. The 30-day major adverse events (MAE) rate was 1.4%, with one target lesion revascularization (TLR), and no deaths or amputations were recorded. Mean stenosis was reduced from 87.8 to 48.5%, with a mean lumen gain of 40.2%. At 12 months, primary patency was 68.4%; secondary patency was 89.7%. Clinical improvement was evidenced by an increase in the mean ankle-brachial index (ABI) from 0.52 ± 0.15 to 0.76 ± 0.18, and 91.7% (66/72) of patients showed an improvement of at least one Rutherford class after 1 year. Conclusions This study confirms the Jetstream system’s clinical value in Chinese FPOAD patients. Its combination of mechanical cutting and aspiration makes it particularly suitable for Asian-specific calcified lesions, achieving favorable clinical outcomes.