Novel Self-Expanding Interwoven Nitinol Stent for Treating Femoropopliteal Artery Disease: 12-Month Results of Single-Center First-in-Man Study.

PURPOSE: To evaluate the safety and efficacy of Innospring® stent, a novel self-expanding interwoven nitinol stent, in treating femoropopliteal atherosclerotic lesions.

METHODS

A prospective, single-center, single-arm, first-in-human study enrolled 15 patients (mean age 73.1 years; 13 men) to evaluate the safety and efficacy of the Innospring® stent monitored by core laboratories. The inclusion criteria were claudication or ischemic rest pain, de novo lesions or nonstented restenosis, >70% stenosis, lesion length <20 cm, and a reference vessel diameter of 4-7 mm. The primary safety endpoint was 30-day major adverse events. The primary efficacy end point was stent patency at 12 months. Follow-up evaluations were conducted at 30 days, 6 months, and 12 months.

RESULTS

The lesion length was 6.1 ± 3.5 mm. Fourteen (93.3%) patients had lesions of the superficial femoral artery and 3 (20.0%) patients had lesions of the popliteal artery. Nine (60.0%) patients had moderate-to-severe calcified lesion. Technical and procedural success was 100%. No patients experienced major adverse events in the first 30 days. The Rutherford category showed significant and sustained improvement at 6 and 12 months. The 12-month follow-up radiographs obtained in 13 patients confirmed the absence of stent fractures in 100% of examinations. The cumulative primary stent patency rate at 6 and 12 months were 93.3% and 84.6%, respectively.

CONCLUSION

Stenting of the superficial femoral and popliteal arteries using the Innospring® stent is safe and effective. This competing interwoven nitinol stent may provide superior stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress.

CLINICAL IMPACT: Endovascular recanalization is a widely accepted and recommended treatment for symptomatic peripheral artery diseases. The Innospring® stent is a novel self-expanding interwoven stent containing eight nitinol wires with additional radial force, fracture-resistance, and visibility under fluoroscopy. This first-in-human study using the Innospring® stent in patients with femoropopliteal occlusive disease reported that stenting of the superficial femoral and popliteal arteries using the Innospring® stent is safe and effective. This competing interwoven nitinol stent may provide an impressive stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress.