Spur Retrievable Scaffold Therapy (RST): DEEPER REVEAL Clinical Trial 12-Month Outcomes

Purpose: There are limited treatment options to address the anatomical challenges of infrapopliteal arterial disease in patients with chronic limb-threatening ischemia (CLTI), specifically vessel recoil, medial calcification, long lesions, and segment mobility.



The DEEPER REVEAL study was designed to evaluate the safety and efficacy of a novel device, the Spur Peripheral Retrievable Stent System (Spur) in patients with CLTI. The primary endpoints were compared to pre-defined performance goals based on historical rates with percutaneous transluminal angioplasty (PTA) in infrapopliteal arteries.

Materials and Methods: 130 subjects with infrapopliteal disease (140 lesions), Rutherford class 4 and 5, at 49 sites, were enrolled in the study. Subjects were scheduled for follow-up through 12 months. Angiography, wounds, and duplex ultrasound (DUS) were assessed by independent core laboratories. Study oversight was provided by an independent Clinical Events Committee and Data Safety and Monitoring Board.

Results: The primary efficacy and safety endpoints of technical success, defined as < 30% residual stenosis of the treated lesion post procedure and freedom from MALE and perioperative death (POD) at 30 days have been met and previously reported.



The following endpoints have not yet been reported; abstract data is preliminary, and final data will be reported at SIR, 2026. Core lab adjudicated technical success was 85.7% (120/140), and procedure success, defined as acute technical success and absence of major adverse events (MAE) within 72 hours of the index procedure was 99.2% (129/130). At 12 months, improvement in Rutherford class score was 80% (68/85). Primary patency by DUS in subjects with evaluable data was 62.7% (47/75). The occurrence of CDTLR by Kaplan Meier (KM) analysis was 18.1% (21/130)/ Core lab reported complete wound healing was seen in 86% (49/57) of wounds. Additionally, freedom from MALE was 91% (91/100, limb salvage was 93.9% (93/99), and the occurrence of all-cause mortality was 9.7% [KM analysis (11/130)].

Conclusion: The results of the DEEPER REVEAL study demonstrate that the Spur is safe and effective in patients with CLTI, with high technical success rates and significant improvement in patient symptoms of wound healing and Rutherford class score from baseline, and low rates of major amputation. The device was granted FDA De Novo clearance on May 29, 2025, based on the results of the study. The Spur provides a safe and effective treatment options for CLTI patients with infrapopliteal artery disease.