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

Durability of Drug-Eluting Balloon-Mounted Stents in Symptomatic ICAD: A Propensity-Matched Landmark Analysis of RO-ZES Versus Wingspan or Medical Management Beyond 24 Months. (PubMed, Stroke Vasc Interv Neurol) - "Although previous studies have demonstrated the superiority of the Resolute Onyx Zotarolimus-eluting stent compared with the Wingspan system and aggressive medical management for the treatment of severe symptomatic intracranial atherosclerotic disease, the present landmark analysis suggests that these benefits may not consistently extend beyond 24 months. One speculative explanation is that the drug elution-related benefit of the Resolute Onyx Zotarolimus-eluting stent may attenuate over time, but this was not directly assessed in the present study. Prospective, controlled trials are necessary to confirm the implications of our long-term findings."

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

Preclinical Evaluation of a Zotarolimus-Eluting Stent for Intracranial Application: A 30-Day Procedural Feasibility and Clinical Observation Canine Study. (PubMed, J Neuroimaging) - "Implantation of the Onyx Frontier ZES is highly feasible in sub-2 mm, tortuous intracranial vessels. The platform demonstrated an excellent 30-day clinical safety profile, providing essential procedural and early clinical data to support future integrated regulatory evaluations for ICAD."

Journal • Preclinical • Atherosclerosis • Cardiovascular • Giant Cell Arteritis • Inflammation

Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial. (PubMed, Eur Heart J Acute Cardiovasc Care) - P4 | "HBR patients with ACS are at higher risk of cardiac death than those without ACS and experience a consistent outcome with BP-SES or DP-ZES followed by 1 month DAPT at 1 year follow-up."

Journal • Acute Coronary Syndrome • Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis

IRIS-Onyx Cohort in the IRIS-DES Registry (clinicaltrials.gov) - P=N/A | N=4500 | Active, not recruiting | Sponsor: Seung-Jung Park | Trial completion date: Dec 2030 ➔ Dec 2031 | Trial primary completion date: Dec 2026 ➔ Dec 2027

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

Sex-Based Outcomes in Patients With High Bleeding Risk After PCI With 1-Month DAPT: Results From the Onyx ONE Clear Study. (PubMed, J Soc Cardiovasc Angiogr Interv) - "In HBR patients treated with Resolute Onyx ZES and 1-month abbreviated DAPT, rates of CD or MI at 2 years were low, with no significant sex-related differences in ischemic and bleeding events. These data support the use of abbreviated DAPT after ZES in women and men with HBR."

Journal • Acute Coronary Syndrome • Cardiovascular • Diabetes • Metabolic Disorders • Myocardial Infarction

Side Branch Additional Treatment for Coronary Bifurcation Lesion Revascularization: Insights From the KISS Randomized Trial. (PubMed, JACC Cardiovasc Interv) - "The KISS trial demonstrates that a conservative strategy without systematic SB intervention is associated with very rare procedural complications and is noninferior to a systematic SB intervention regarding periprocedural MI and myocardial injury."

Clinical • Journal • Cardiovascular • Myocardial Infarction

HOST REDUCE POLYTECH RCTt: Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS Patients (HOST REDUCE POLYTECH RCT Trial) (clinicaltrials.gov) - P4 | N=3429 | Completed | Sponsor: Seoul National University Hospital | Unknown status ➔ Completed

Trial completion • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease

ONYSOVER: Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: Yonsei University | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Coronary Artery Disease

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

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

MeRethonRCT: Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Meril Life Sciences Pvt. Ltd. | N=1872 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • First-in-human • Head-to-Head • Trial withdrawal • Cardiovascular • Coronary Artery Disease

"Roundabout" Bailout Stenting for Subacute Right Coronary Artery Obstruction After Self-Expandable Transcatheter Aortic Valve Replacement. (PubMed, JACC Case Rep) - "A "roundabout" approach via the adjacent cusp may allow coronary access and revascularization when the coronary sinus is sequestered."

Journal • Cardiovascular

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 | Completed | Sponsor: Stanford University | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Coronary Artery Disease

Postpartum Spontaneous Coronary Artery Dissection Involving the Left Main Coronary Artery: A Case Report. (PubMed, Int J Womens Health) - "A 3.0 ×22-mm Endeavor Resolute stent was implanted in the proximal LM and left anterior descending coronary arteries...However, after withdrawal of the IABP and VA-ECMO, the patient's symptoms worsened, and she died while awaiting heart transplantation. We report a rare case of PSCAD involving the LM coronary artery with the aim of enhancing clinicians' understanding of PSCAD and providing insights for treatment approaches."

Journal • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Myocardial Infarction • Pain • Transplantation

Submaximal Stenting' for Rescue Therapy in Large Vessel Occlusion (LVO) Acute Ischemic Stroke Secondary to Intracranial Atherosclerotic Disease (ICAD): A Single-Center Case Series (ISC 2026) - "All patients underwent follow-up vascular imaging. Complications are illustrated based on duration since admission in Figure 2 .Conclusions Submaximal stenting with Resolute Onyx™ and Onyx Frontier™ DES is technically feasible and appears safe as rescue therapy for acute IS related to ICAD-LVO."

Clinical • Atherosclerosis • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke • Thrombosis

Comparative effectiveness of percutaneous coronary intervention strategies for coronary small-vessel disease: a network meta-analysis of randomized trials. (PubMed, Ann Med) - "For TLR (37 studies; 11,980 patients), the highest SUCRA values were observed with sirolimus-eluting stents (SES 90.1%), zotarolimus-eluting stents (ZES 83.9%), and everolimus-eluting stents (EES 82.2%). ZES, EES, and DCB-PTX are effective alternatives in selected settings, whereas BMS, POBA, and GPBA are less effective. These findings offer comparative evidence to guide device selection in SVD."

Clinical • HEOR • Journal • Retrospective data • Review • Cardiovascular • Myocardial Infarction

A prospective, multicenter, randomized controlled study to evaluate the safety and efficacy of PTCA drug balloon catheter in the treatment of coronary artery lesions in situ (ChiCTR) - P=N/A | N=370 | Completed | Sponsor: The First Affiliated Hospital of the Air Force Medical University; The First Affiliated Hospital of the Air Force Medical University

New trial

Recurrent coronary artery in-stent restenosis caused by metal allergy: a case report. (PubMed, Front Cardiovasc Med) - "The first ISR occurred after implantation of a nickel-rich Medtronic Endeavor Resolute stent (35% nickel, 35% cobalt, and 20% chromium)...The article discusses this special case and clinically relevant management options. This case highlights a scenario with refractory in-stent restenosis persisting despite various treatment strategies, including stents with different metal components, drug-coated balloons, and intensive drug therapy."

Journal • Allergy • Immunology

Short dual antiplatelet therapy after PCI with Resolute Onyx drug-eluting stents in high bleeding risk patients: One-year outcomes from a South Asian cohort. (PubMed, Am Heart J Plus) - "All patients received DAPT (aspirin 75 mg + ticagrelor 90 mg BID) for three months, followed by ticagrelor monotherapy for nine months. In this real-world HBR cohort treated with Resolute Onyx ZES, a strategy of 3-month DAPT followed by ticagrelor monotherapy was associated with low rates of ischemic events and the absence of major bleeding at one year. These findings suggest a favorable safety-efficacy balance for DAPT de-escalation in carefully selected patients; however, this requires confirmation in larger, prospective studies."

Journal • Acute Coronary Syndrome • Cardiovascular • Diabetes • Hematological Disorders • Metabolic Disorders • Myocardial Infarction • Thrombosis

IRIS-Onyx Cohort in the IRIS-DES Registry (clinicaltrials.gov) - P=N/A | N=4500 | Active, not recruiting | Sponsor: Seung-Jung Park | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Coronary Artery Disease

Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial) (clinicaltrials.gov) - P=N/A | N=300 | Active, not recruiting | Sponsor: Carelon Research | Trial completion date: Apr 2027 ➔ Feb 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2027

Trial completion date • Trial primary completion date • Cardiovascular • Heart Failure

IRIS-Onyx Cohort in the IRIS-DES Registry (clinicaltrials.gov) - P=N/A | N=4500 | Recruiting | Sponsor: Seung-Jung Park | Trial completion date: Dec 2029 ➔ Dec 2030 | Trial primary completion date: Dec 2025 ➔ Dec 2026

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

Clinical and Angiographic Outcomes of Cardiac Balloon-Mounted Stents for Symptomatic Intracranial Stenosis. (PubMed, Oper Neurosurg) - "The Resolute/Frontier stent demonstrated favorable safety and efficacy in this cohort, with low procedural complication rates and no recurrent strokes or intracranial hemorrhages at follow-up. These findings, along with previous evidence supporting drug-eluting stents, highlight the potential of Resolute/Frontier Onyx as a promising therapeutic option for symptomatic ICAD."

Journal • Atherosclerosis • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Hypertension

Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial) (clinicaltrials.gov) - P=N/A | N=300 | Active, not recruiting | Sponsor: Carelon Research | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Heart Failure

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