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Comparative Evaluation of Sustained Mechanical Aspiration Thrombectomy and No Thrombus Modification for Pre-stent Thrombus Burden Reduction in Patients With Acute Myocardial Infarction

Reference: NCT07687576

Status: Recruiting

Started: June 2026

Enrolment Target : 60 patients

Chief Investigator: Dr Giovanni L. De Maria

Clinical Area: ST-segment elevation myocardial infarction (STEMI)

Study Aim: CAPTURE AMI is a prospective randomised trial evaluating whether sustained mechanical thrombectomy before stent implantation reduces coronary thrombus burden in patients presenting with STEMI. The study aims to determine whether this strategy improves procedural outcomes compared with conventional primary PCI alone.

Randomised EValuation of Therapies for microvAscuLar Injury in STEACS

Reference: NCT06935383

Status: Recruiting

Started: May 2026

Enrolment Target : 250 patients

Chief Investigator: Dr Giovanni L. De Maria

Clinical Area: ST-segment elevation myocardial infarction (STEMI)

Study Aim: International, multicentre, randomised controlled trial evaluating whether the CorFlow CoFI® platform can identify coronary microvascular obstruction immediately after primary PCI and enable targeted intracoronary therapy to improve myocardial recovery following STEMI. It is the first adaptive platform trial in STEMI, providing an innovative framework for evaluating emerging therapies targeting the coronary microcirculation.

Reference: NCT06887413

Status: Recruiting

Started: September 2026

Enrolment Target : 140 patients

Chief Investigator: Dr Giovanni L. De Maria

Clinical Area: ST-segment elevation myocardial infarction (STEMI)

Study Aim: International, multicentre, randomised controlled trial evaluating whether sustained mechanical thrombectomy using the Indigo® Aspiration System during primary PCI reduces coronary microvascular obstruction and infarct size compared with conventional primary PCI in patients presenting with anterior STEMI. The primary endpoint is CMR-derived microvascular obstruction measured 3–5 days after reperfusion.

Thrombus Aspiration With CathRx in Anterior Myocardial Infarction

CoronarY CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes

Reference: NCT06678594

Status: Recruiting

Started: April 2026

Enrolment Target : 440 patients

Local (Oxford) Investigator: Dr Giovanni L. De Maria

Clinical Area: Calcified Coronary Artery Disease - Complex PCI

Study Aim: International, multicentre, single arm registry to evaluate whether implementation of a standardized IVUS-guided algorithm for coronary calcium modification improves procedural success and clinical outcomes in patients undergoing PCI for severely calcified coronary artery disease

Development of radioMics approach to assess perivascular fat modification and to predict blood pressure respOnse after renaL artery dEnervation.

Reference: IRAS ID 335877

Status: Recruiting

Started: January 2025

Enrolment Target : 128 patients

Chief Investigator: Dr Giovanni L. De Maria

Clinical Area: arterial hypertension , renal denervation

Study Aim: single-arm registry, aiming at understanding and characterising radiological features of the adipose tissue around the renal artery pre- and post renal denervation, as a way to achieve better selection of patients who can truly benefit from the procedure, guiding optimal delivery of renal denervation and identifying where a repeat procedure would be useful if the first one was incomplete

Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)

Reference: NCT07115953

Status: Recruiting

Started: January 2026

Enrolment Target : 130 patients

Local (Oxford) Investigator: Dr Giovanni L. De Maria

Clinical Area: arterial hypertension , renal denervation

Study Aim: To evaluate whether a streamlined renal denervation strategy targeting the main and first-order branch renal arteries with the Symplicity Spyral™ system can reduce procedure time while maintaining the blood pressure-lowering efficacy of conventional multivessel renal denervation. The study forms part of the international SPYRAL AFFIRM programme evaluating the long-term safety, efficacy, and durability of renal denervation in patients with uncontrolled hypertension

Predictive Value of Cardiac CT in Assessing Procedural Complexity for Coronary Sinus Reducer Implantation

Reference: IRAS ID 335877

Status: Recruiting

Started: January 2025

Enrolment Target : 75 patients

Local (Oxford) Investigator: Dr Giovanni L. De Maria

Clinical Area: Refractory Angina / Coronary Microvascular Dysfunction

Study Aim: multi-centre, single-arm registry, aiming at understanding the predictive capability of cardiac CT in assessing coronary sinus reducer implantation complexity through anatomical visualization of the coronary sinus; examine correlations between cardiac CT findings and procedural outcomes and to gather preliminary data to develop a prediction score that will be validated in a larger, multicentre trial.

Reference: NCT05102019

Status: Recruiting

Started: November 2025

Enrolment Target : 380 patients

Local (Oxford) Investigator: Dr Giovanni L. De Maria

Clinical Area: Refractory Angina

Study Aim: Sham-controled, double blind randomized clincal trial to evaluate the safety and effectiveness of the Shockwave Reducer™ in improving symptoms and quality of life in patients with refractory angina through a multicentre, international, randomised, double-blind, sham-controlled trial. The study also includes dedicated registries for patients with ANOCA and other challenging clinical presentations

COronary SInus Reducer for Treatment of Refractory Angina II

Reference: NCT07337005

Status: Recruiting

Started: April 2026

Enrolment Target : 220 patients

Local (Oxford) Investigator: Dr Giovanni L. De Maria

Clinical Area: ANOCA / INOCA - Coronary Microvascular Dysfunction - Coronary Vasospasm

Study Aim: To evaluate the feasibility, safety, and diagnostic performance of a comprehensive invasive coronary function testing protocol integrating continuous thermodilution, endothelial function assessment, and vasospasm testing to improve the diagnosis and phenotyping of coronary microvascular and vasomotor dysfunction

CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction

Reference: NCT07422688

Status: Recruiting

Started: September 2026

Enrolment Target : 3000 patients

Local (Oxford) Investigator: Dr Giovanni L. De Maria

Clinical Area: Acute Coronary Syndromes - Optical Coherence Tomography - PCI

Study Aim: international multicentre randomized clinical trial to determine whether routine OCT-guided PCI improves one-year clinical outcomes compared with conventional angiography-guided PCI in patients presenting with acute coronary syndromes.

Optical Coherence Tomography in Acute Vessel Evaluation

Reference: to be assigned

Status: Setting Up phase

Started: not yet

Enrolment Target : N/A

Local (Oxford) Investigator: Dr Giovanni L. De Maria

Clinical Area: complex coronary intervention - acute coronary syndrome - refractory angina - ANOCA/INOCA

Study Aim: prospective long-term registry to evaluate the real-world application and outcomes of contemporary interventional strategies in complex coronary artery disease

The Oxford Coronary Registry – Prospective and Retrospective Evaluation of Complex Coronary Artery Disease Managed with Interventional Procedures

Completed

Stent-Retriever Thrombectomy for Thrombus Burden Reduction in Patients with Acute Myocardial Infarction

Reference: NCT05307965

Status: Completed & Published

Enrolment Target : 81 patients

Chief Investigator: Dr Giovanni L. De Maria

Clinical Area: ST-segment elevation myocardial infarction (STEMI)

Study Aim: To evaluate the safety and efficacy of stent-retriever thrombectomy for reducing coronary thrombus burden in patients with STEMI undergoing primary PCI, compared with conventional manual aspiration thrombectomy or PCI alone.

Publication: Kotronias RA, Walsh JL, Andreaggi S, et al. Stent-Retriever Thrombectomy in STEMI With Large Thrombus Burden: The RETRIEVE AMI Randomized Trial. JACC: Advances. 2025;4(7):101893.

Links: https://pubmed.ncbi.nlm.nih.gov/40555011/

Pressure-controlled Intermittent Coronary Sinus Occlusion in Acute Myocardial Infarction

Reference: NCT03625869

Status: Completed & Published

Enrolment Target : 145 patients

Local (Oxford) Investigator: Prof Adrian Banning

Clinical Area: ST-Elevation Myocardial Infarction (STEMI)

Study Aim: International multicentre randomised clinical trial to determine whether adjunctive Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO®) initiated immediately after restoration of coronary flow and before stent implantation reduces infarct size and coronary microvascular injury compared with conventional primary PCI in patients presenting with anterior STEMI.

Publication: De Maria GL, Greenwood JP, Zaman AG, et al. Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction: The PiCSO-AMI-I Trial. Circulation: Cardiovascular Interventions.2024;17:e013675.

Links: https://pubmed.ncbi.nlm.nih.gov/38626079/

Reference: NCT03473015

Status: Completed & Published

Enrolment Target : 105 patients

Chief Investigator: Prof Adrian Banning

Clinical Area: ST-Elevation Myocardial Infarction (STEMI)

Study Aim: simgle cemtre propensity matched clincial study to determine whether Index of Microcirculatory Resistance (IMR)-guided Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO®) improves coronary microvascular function and reduces infarct size in patients with anterior STEMI undergoing primary PC

Publication: De Maria GL, Alkhalil M, Borlotti A, et al. Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the OxAMI-PICSO study. EuroIntervention. 2018;14:e352–e359

Links: https://pubmed.ncbi.nlm.nih.gov/29792403/

Oxford Acute Myocardial Infarction – Pressure-controlled Intermittent Coronary Sinus Occlusion

OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound

Reference: NCT04111770

Status: Completed & Published

Enrolment Target : 806 patients

Chief Investigator: Prof Adrian Banning

Clinical Area: Complex PCI - Left Main Stem PCI

Study Aim: International multicentre randomised clinical trial to determine whether IVUS-guided PCI improves clinical outcomes compared with conventional angiography-guided PCI in patients undergoing percutaneous revascularisation of unprotected left main coronary artery disease.

Publication: Testa L, De la Torre Hernandez JM, De Maria GL, et al. IVUS-Guided versus Angiography-Guided PCI in Unprotected Left Main Coronary Disease. New England Journal of Medicine. 2026.

Links: https://pubmed.ncbi.nlm.nih.gov/40555011/

Functional Assessment by Three-dimensional Angiography for Safe Treatment III

Reference: NCT04931771

Status: Completed & Published

Enrolment Target : 2211 patients

Local (Oxford) Investigator: Prof Adrian Banning

Clinical Area: Coronary Physiology - Stable Coronary Artery Disease - Acute Coronary Syndromes

Study Aim: International multicentre randomised clinical trial to determine whether angiography-derived vessel fractional flow reserve (vFFR) is non-inferior to pressure wire-based fractional flow reserve (FFR) for guiding coronary revascularisation in patients with intermediate coronary lesions

Publication: Daemen J, van der Eijk JA, Barbierato M, et al. Angiography-Based Physiology to Guide Coronary Revascularization. New England Journal of Medicine. 2026;395:20–31

Links: https://pubmed.ncbi.nlm.nih.gov/41910382/

Reference: NCT04854070

Status: Completed & Published

Enrolment Target : 2020 patients

Local (Oxford) Investigator: Prof Adrian Banning

Clinical Area: Complex High-Risk PCI (CHIP) - Intravascular Imaging

Study Aim: International multicentre randomised clinical trial to determine whether a strategy of routine IVUS-guided PCI, using prespecified stent optimisation criteria, improves clinical outcomes compared with conventional angiography-guided PCI in patients undergoing complex high-risk coronary intervention.

Publication: Van Mieghem NM, Diletti R, Daemen J, et al. Intravascular Ultrasound-Guided or Angiography-Guided Complex High-Risk PCI. New England Journal of Medicine. 2026;394:2200–2211.

Links: https://pubmed.ncbi.nlm.nih.gov/41911016/

Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

The Global Paradise® System (GPS) Registry

Reference: NCT05027685

Status: Completed in Follow Up

Enrolment Target : 3000 patients

Local (Oxford) Investigator: Dr Giovanni L. De Maria

Clinical Area: Uncontrolled Hypertension - Renal Denervation

Study Aim: International multicentre registry to evaluate the long-term safety, effectiveness and real-world performance of the Paradise™ Ultrasound Renal Denervation System in patients undergoing renal denervation for hypertension

European microCirculatory Resistance and Absolute Flow Team Registry

Reference: NCT04598308

Status: Completed in Follow Up

Enrolment Target : 678 patients

Local (Oxford) Investigator: Dr Giovanni L. De Maria

Clinical Area: Coronary Microvascular Dysfunction - ANOCA/INOCA - Coronary Physiology

Study Aim: European multicentre registry to determine the clinical utility and prognostic value of invasive assessment of absolute coronary blood flow and microvascular resistance using continuous thermodilution, and to establish contemporary reference data for the diagnosis and management of coronary microvascular dysfunction.

Reference: NCT05540223

Status: Completed in Follow Up

Enrolment Target : 1861 patients

Local (Oxford) Investigator: Prof Adrian Banning

Clinical Area: Coronary Artery Disease - Bioresorbable Scaffolds

Study Aim: European multicentre randomized clinical trial to determine whether the Freesolve® sirolimus-eluting resorbable magnesium scaffold is non-inferior to a contemporary drug-eluting stent for the treatment of de novo coronary artery lesions in an international randomized controlled trial.

Safety and Clinical Performance of the Drug-Eluting Resorbable Coronary Magnesium Scaffold System

Reference: NCT02015832

Status: Completed & Published

Enrolment Target : 465 patients

Chief Investigator: Prof Adrian Banning

Clinical Area: Multivessel Coronary Artery Disease • Complex PCI • Coronary Physiology • IVUS

Study Aim: To evaluate whether a contemporary PCI strategy incorporating Heart Team decision-making, SYNTAX Score II, coronary physiology (iFR/FFR), IVUS guidance, thin-strut drug-eluting stents and guideline-directed medical therapy improves clinical outcomes in patients with complex three-vessel coronary artery disease.

Publication: Escaned J, Collet C, Ryan N, et al. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three-vessel disease: 1-year results of the SYNTAX II study. European Heart Journal.2017;38:3124–3134.

Banning AP, Serruys PW, De Maria GL, et al. Five-year outcomes after state-of-the-art percutaneous coronary revascularization in patients with de novo three-vessel disease: final results of the SYNTAX II study. European Heart Journal. 2022;43:1307–1316

Links: https://pubmed.ncbi.nlm.nih.gov/28911005/ https://pubmed.ncbi.nlm.nih.gov/34617993/

Synergy Between PCI with TAXUS and Cardiac Surgery II

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ORIIC is the public identity of an established multidisciplinary cardiovascular research group bringing together members from Oxford University Hospitals NHS Foundation Trust, the University of Oxford and collaborating institutions. Individual research activities remain governed by their respective sponsoring institutions.