Table 3.
Current polymer-free stents undergoing clinical evaluation
| Stent | Study | Platform | Drug | Primary endpoint | Design | Randomized ratio | Stent comparisons (n) | Result |
| Yukon (Translumina) | ISAR TEST[50] | 316 L microporous surface | Sirolimus + Probucol | MACE/ST at 1yr | RCT | 2:1 | Yukon/R-ZES 3002 (2002/1000) | Noninferior |
| Cre 8 (CID) | NEXT[51] | CoCr abluminal reservoirs | Amphilimus | LL at 6 mo | RCT | 1:1 | Cre 8/PES 323 (162/161) | Superior |
| BioFreedom DCS (Biosensors) | BioFreedom FIM[52] | 316 L microstructured surface | Biolimus A9 | LL at 12 mo | RCT | 1:1:1 | Standard dose/low dose Biofreedom/PES 182 (60/62/60) | Noninferior |
| Vestasync (MIV therapeutics) | VESTASYNC Il[53] | 316 L microporous nanofilm Hap | Sirolimus | LL at 4 and 9 mo | RCT | 2:1 | VESTAsync/BMS 75 (50/25) | Superior |
| Amazonia Pax (Minvasys) | Pax A and Pax B | CoCr nontextured | Paclitaxel | LL at 6 mo | RCT | 1:1 | PAXA/PES 30 (15/15), PAXB = 100 | Noninferior |
| Yinyi (Liaoning Biomed.Mat) | FREEDOM[54] | 316 L micropores | Paclitaxel | MACE/ST/TVR | RCT | 2:1 | Yinyi/SES 1626 (931/449) | Noninferior |
| Bicare+ (Lepu Medical) | BICARE[56] | 316 L | Sirolimus + Probucol | TVF at 30 d | FIM | - | n = 32 | TVF = 9.4%, LL 0.14, ISR = 3.2% |
| Pronova XR (Vascular Concepts) | EURONOVA XR l[55] | Co-Cr | Sirolimus | LL at 6 mo | FIM | - | n = 50 | In-stent LL 0.45 |
| Focus NP (Envision Scientific) | Nano active FIM | 316 L nontextured | Sirolimus nanoparticles | LL at 6 mo | FIM | - | n = 100 | Ongoing |
| Mitsu (Meril Medical) | - | CoCr ultrathin struts | Merilimus | - | - | - | Planned | - |
| Hollow-core DFS (Medtronic) | - | CoCr holes and hollow tube | Sirolimus | - | - | - | Planned | - |
| Nano+ (Lepu medical) | Nano+ | Microporous | Sirolimus | OCT evaluation | FIM | - | n = 45 | Ongoing |
MACE: Major adverse cardiac events; ST: Stent thrombosis; RCT: Randomized control trial; LL: Late lumen loss; R-ZES: Resolute zotarolimus-eluting stents; PES: Paclitaxel-eluting stents; BMS: Bare metal stents; SES: Sirolimus-eluting stents; TVR: Target vessel revascularization; TVF: Target vessel failure; ISR: In-stent restenosis; OCT: Optical coherence tomography; FIM: First-in-man trial.