Resolute ZES (zotarolimus-eluting stent) / Medtronic - LARVOL DELTA

RESOLUTE ONYX China RCT Study (clinicaltrials.gov) - P=N/A | N=550 | Active, not recruiting | Sponsor: Medtronic Vascular | Trial completion date: Sep 2025 ➔ Apr 2026

Trial completion date • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Heart Failure

RESOLUTE ONYX China Single Arm Study (clinicaltrials.gov) - P=N/A | N=591 | Active, not recruiting | Sponsor: Medtronic Vascular | Trial completion date: Oct 2025 ➔ Apr 2026

Trial completion date • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Heart Failure

ONYSOVER: Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Yonsei University | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cardiovascular • Coronary Artery Disease

A randomized prospective study investigating the relationship between post-PCI wall shear stress and 12-month neointimal healing: The SHEAR-STENT study. (PubMed, Cardiovasc Revasc Med) - P=N/A | "The SHEAR-STENT study demonstrated no significant differences in WSS or NIT at 12 months between R-ZES and X-EES. A wide range of patient level correlation coefficients between WSS and NIT were observed, with some patients showing increased NIT was associated with low WSS and others associated with high WSS."

Journal • Diabetes • Dyslipidemia • Metabolic Disorders • Nephrology • Renal Disease

Single-center outcomes of Onyx drug-eluting balloon-mounted stents for neurovascular atherosclerotic disease. (PubMed, Interv Neuroradiol) - "Independent predictors of complications included posterior circulation stenting (OR 13.8, p = .005), smaller stent diameter (OR 0.17, p = .03), and higher stent number (OR 14.7, p < .0001).ConclusionOnyx DES demonstrated excellent navigability, high technical success, and favorable long-term outcomes in patients with neurovascular atherosclerotic lesions. Together with growing comparative evidence, these findings suggest newer-generation DES may overcome limitations of earlier stent systems and merit further prospective evaluation."

Journal • Atherosclerosis • Cardiovascular

Complex all-comers and patients with diabetes and prediabetes treated with Xience Sierra everolimus-eluting stents: COASTLINE high-risk. (PubMed, Eur Heart J Open) - P=N/A | "After enrolment, HR patients were identified according to prespecified criteria, and per protocol compared with HR patients treated in two randomized all-comer trials with Resolute-type zotarolimus-eluting stents (ZES). The significant difference in TVMI was driven by periprocedural events, as a landmark analysis at 7 days found no between-stent differences. https://clinicaltrials.gov/study/NCT04475380."

Journal • Cardiovascular • Coronary Artery Disease • Diabetes • Metabolic Disorders • Myocardial Infarction

TREATMENT OF HYPERTENSIVE EMERGENCY AND FLASH PULMONARY EDEMA WITH RENAL ARTERY STENTING: A REVIEW OF PICKERING SYNDROME (CHEST 2025) - "He was managed with oxygen therapy via face mask as well as intravenous nitroglycerin infusion...Renal angiography identified a 95% right renal artery stenosis and was successfully treated with angioplasty and deployment of a Resolute Onyx 4.0mm x 34mm stent... Our patient was treated with intravascular ultrasound-guided stent placement resulting in cardiopulmonary stabilization. The management in our case suggests that renal artery intervention should be considered in patients presenting with unilateral renal artery stenosis and cardiac destabilization such as flash pulmonary edema even in the setting of a functioning contralateral kidney."

Review • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • CNS Disorders • Depression • Heart Failure • Hypertension • Psychiatry • Respiratory Diseases

IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact (clinicaltrials.gov) - P=N/A | N=3100 | Active, not recruiting | Sponsor: Medstar Health Research Institute | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2027 ➔ Sep 2026

Enrollment closed • HEOR • Trial primary completion date • Atherosclerosis • Cardiovascular

Zotarolimus-eluting stent in complex lesions versus non-complex lesions from Japanese all-comers registry (ESC-WCC 2025) - "ZES showed decent clinical result in complex lesions and non-complex lesions from Japanese real-world data."

Cardiovascular • Myocardial Infarction

Characteristics and Success of Intentional Stent Fracture in Drug-Eluting Coronary Stents for Use in Congenital Heart Disease. (PubMed, Pediatr Cardiol) - "A total of 61 stents were tested: Resolute Onyx small (3.5-4.0 mm, n = 9, 15%), Resolute Onyx large (4.5-5.0 mm, n = 11, 18%), Synergy XD (3.5-4.0 mm, n = 13, 21%), Synergy Megatron (3.5-5.0 mm, n = 15, 25%), and Xience Skypoint (3.5-5.0 mm, n = 13, 21%). Dilation of DES platforms using a standardized serial dilation protocol results in a high rate of intentional fracture with minimal foreshortening in ex vivo bench testing. These results may aid congenital interventional cardiologists using DES for CHD in the selection of stents and optimal techniques for intentional fracture in vivo."

Journal • Cardiovascular • Heart Failure • Musculoskeletal Diseases

Assessing mortality rates and predictors of cardiac death in diabetic and non-diabetic patients after left main percutaneous coronary intervention with the Resolute zotarolimus-eluting stent in Bangladesh: a comprehensive analysis. (PubMed, AsiaIntervention) - "The use of the Resolute ZES was associated with comparable outcomes in diabetic and non-diabetic patients undergoing left main PCI. Age, renal function, and certain procedural techniques are key predictors of cardiac death, emphasising the need for individualised patient assessment in LMCA disease management."

Journal • Cardiovascular • Coronary Artery Disease • Metabolic Disorders

Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial. (PubMed, Heart) - P4 | "The SUGAR trial demonstrates that AES and O-ZES provide comparable long-term efficacy in preventing TLF in patients with DM undergoing PCI. These findings support the use of either stent type and highlight the importance of further long-term studies to optimise outcomes."

Journal • Cardiovascular • Coronary Artery Disease • Diabetes • Hematological Disorders • Metabolic Disorders • Myocardial Infarction • Thrombosis

Patient-tailored stent: are we there yet? (PubMed, Cardiol J) - "We concluded that the current evidence may encourage the use of (i) sirolimus-eluting stents (SES) in small vessel disease, (ii) biodegradable-polymer SES in multivessel PCI, (iii) everolimus-eluting stents (EES) and zotarolimus-eluting stents in bifurcation lesions, (iv) EES in chronic total occlusions, (v) SES, EES, and polymer-free stents in diabetic patients, (vi) ultrathin biodegradable-polymer DES and titanium-nitride-oxide-coated stents in acute coronary syndrome, and (vii) polymer-free biolimus-eluting stents in high bleeding-risk patients. Further randomized trials are required to established firm recommendations."

Journal • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Diabetes • Hematological Disorders • Metabolic Disorders • Thrombosis

Late stent strut apposition and coverage after drug-eluting stent implantation by optical coherence tomography in patients with acute myocardial infarction. (PubMed, Coron Artery Dis) - P=N/A | "Twelve-month OCT measurements showed no significant differences in late SM and uncovered struts between the BP-EES and DP-ZES stents. Thus, contemporary second-generation DES show a very low rate of late SM and uncovered struts after 12 months in AMI, regardless of stent polymer type."

Journal • Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis

Long-term outcomes of resolute Onyx Zotarolimus-eluting stents for symptomatic intracranial stenosis: A multicenter propensity score-matched comparison with stenting versus aggressive medical management for preventing recurrent stroke in intracranial stenosis trial. (PubMed, Interv Neuroradiol) - "Multivariable Cox regression demonstrated that RO-ZES stenting lowered the hazard of recurrent strokes compared with PTAS (hazard ratio = .36, 95% CI [0.16-0.80], p = .012).ConclusionTreatment of severe, symptomatic ICAD using RO-ZES was associated with lower odds of recurrent strokes compared with PTAS in this long-term follow-up study. Further prospective trials comparing MM with novel stent technologies are necessary."

Clinical • Journal • Atherosclerosis • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke

FRAGMENTS AND FLOW: A CASE OF GUIDEWIRE FRAGMENTATION COMPOUNDED BY SUBOPTIMAL CORONARY REPERFUSION - Mallory Vaughn (ACC 2025) - "The lesion involving the LAD was intervened upon with two overlapping Resolute Onyx drug-eluting stents. No reflow persisted on angiography despite intra-coronary adenosine and sodium nitroprusside and a 50cc intra-aortic balloon pump was placed for 24 hours. Repeat angiography done 2 days later showed spontaneous return of TIMI 2-3 flow."

Clinical • Breast Cancer • Chronic Obstructive Pulmonary Disease • Dyslipidemia • Immunology • Oncology • Pain • Respiratory Diseases • Solid Tumor

A PROSPECTIVE OCT STUDY INVESTIGATING THE RELATIONSHIP BETWEEN POST-PCI WALL SHEAR STRESS AND 12-MONTH NEOINTIMAL HEALING: THE SHEAR-STENT STUDY - Sheriff Dodoo (ACC 2025) - "We designed a prospective, randomized trial to investigate the influence of WSS on neointimal healing as assessed by OCT in angulated arteries undergoing percutaneous coronary intervention. Eighty-six patients were randomized to Xience Xpedition (X-EES) or Resolute Integrity/Onyx (R-ZES) drug-eluting stents. The SHEAR-STENT study demonstrated no significant differences in WSS or NIT at 12 months between R-ZES and X-EES. Some patients showed increased NIT was associated with low WSS and others that increased NIT was associated with high WSS."

Clinical

ZOTAROLIMUS-ELUTING STENT IN COMPLEX LESIONS VERSUS NON-COMPLEX LESIONS FROM JAPANESE ALL-COMER REGISTRY - Hiroyoshi Mori (ACC 2025) - "ZES showed decent clinical result in complex lesions in comparison with non-complex lesions from Japanese all-comer registry."

Cardiovascular • Myocardial Infarction

Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial. (PubMed, Lancet) - P=N/A | "At the 5-year follow-up, there was no significant difference in a composite outcome of death, stroke, or myocardial infarction after FFR-guided PCI versus CABG, although myocardial infarction and repeat revascularisation were higher with PCI. These results provide contemporary evidence to allow improved shared decision making between physicians and patients."

Journal • Cardiovascular • Coronary Artery Disease • Heart Failure • Myocardial Infarction

OCT-Guided covered stent implantation for acquired coronary aneurysm after bioresorbable vascular scaffold: case report. (PubMed, Future Cardiol) - "Optical coherence tomography (OCT) confirmed a 5.88 mm aneurysm, which was treated with a PK Papyrus covered stent, while the proximal LAD stenosis was addressed with a Resolute Onyx drug-eluting stent (DES)...At the nine-month follow-up, the patient remained symptom-free. This case highlights the utility of OCT in evaluating CAAs and guiding covered stent deployment, while prolonged DAPT may help reduce the risk of very late stent thrombosis and future ischemic events, though further studies are needed."

Journal • Cardiovascular • Coronary Artery Disease • Hematological Disorders • Thrombosis

FAME 3: A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease (clinicaltrials.gov) - P=N/A | N=1500 | Active, not recruiting | Sponsor: Stanford University | Trial completion date: Dec 2024 ➔ Apr 2025

Trial completion date • Cardiovascular • Coronary Artery Disease

Comparison of Thick Biolimus A9-Eluting Stent and Thin Zotarolimus-Eluting Stent in Multi-Vessel Percutaneous Coronary Intervention. (PubMed, Korean Circ J) - P=N/A | "In patients who underwent multi-vessel PCI, BES and ZES showed comparable 2-year clinical outcomes. However, BES was not established to demonstrate non-inferiority to ZES in terms of the incidence of the primary endpoint at the 2-year. The technical success rate of the index PCI with the assigned stent was higher for thinner ZES."

Journal • Cardiovascular • Myocardial Infarction

Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent: 2-Year Outcomes From BIOADAPTOR RCT. (PubMed, JACC Cardiovasc Interv) - P=N/A | "This is the first report of 2-year outcomes comparing the bioadaptor implant with a contemporary drug-eluting stent. At 2-year follow-up, fewer TLF events were observed in patients treated with the bioadaptor. (The Elixir Bioadaptor vs. the Onyx Stent in De Novo Native Coronary Arteries [BIOADAPTOR RCT]; NCT04192747)."

Clinical • Journal • Cardiovascular • Coronary Artery Disease • Hematological Disorders • Thrombosis

Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up. (PubMed, Clin Res Cardiol) - P=N/A | "In elderly all-comer patients, those treated with Onyx ZES showed a lower 5-year incidence of the main endpoint of safety and efficacy, as well as several secondary endpoints, than patients treated with Orsiro SES. Further research on this issue is warranted."

Clinical • Journal • Cardiovascular • Coronary Artery Disease • Myocardial Infarction

A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease (clinicaltrials.gov) - P=N/A | N=277 | Completed | Sponsor: DK Medical Technology (Suzhou) Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Apr 2024

Trial completion • Trial completion date