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

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.