Comparative Evaluation of Sustained meChanical AsPiration Thrombectomy and no Thrombus Modification for Pre-stent Thrombus bUrden Reduction in Patients With Acute Myocardial Infarction Study: the CAPTURE AMI Study

NCT07687576 | Recruiting Phase 2

• 1 other identifier: 19672
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The CAPTURE AMI trial is an investigator-initiated, single-centre, two-arm, randomised controlled trial. Patients aged ≥ 18 years who present with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) will be enrolled after angiographic evidence of a high thrombus burden (TIMI thrombus grade ≥ 4) and meeting the inclusion criteria laid out in section 9.2 will be 1:1 randomised to receive either standalone PCI (Arm 1) or adjunct sustained mechanical thrombectomy + PCI (Arm 2). The CAPTURE AMI study will enrol specifically patients with: A. Evidence of high thrombus burden on coronary angiography (TIMI thrombus grade ≥ 4) B. Culprit in an artery with a diameter of 3.0 mm or more. The trial is designed to evaluate the efficacy of sustained mechanical thrombectomy versus standalone PCI in patients with a large thrombus burden assessed angiographically, with a pre-stent thrombus burden (%) as the primary imaging endpoint.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

Thrombus; Thrombectomy; Optical Coherence Tomography; Microvascular Injury

Outcome Measures

Primary Outcomes (1)

• Pre stent Thrombus Burden

  Pre stent Thrombus Burden (thrombus volume/lumen volume) evaluated by Optical Coherence Tomography

  Pre stent implantation (Periprocedural)

Other Outcomes (6)

• Clinical Outcomes

  In hospital (Pre-discharge), 30 days & 6 months

• Efficacy of thrombus burden reduction

  Pre stent implantation (Periprocedural)

• Efficacy of thrombus burden reduction

  Pre stent Implantation (Periprocedural)

Study Arms (2)

Standalone PCI

ACTIVE COMPARATOR

Standalone OCT guided PCI

Procedure: Percutaneous Coronary Intervention

PCI & Sustained thrombectomy

EXPERIMENTAL

OCT guided PCI \& Sustained Thrombectomy

Device: Sustained thrombectomy; Procedure: Percutaneous Coronary Intervention

Interventions

Sustained thrombectomy DEVICE

Sustained thrombectomy with the Indigo® System CAT™ RX aspiration catheter

PCI & Sustained thrombectomy

Percutaneous Coronary Intervention PROCEDURE

Optical Coherence Tomography guided Percutaneous Coronary Intervention

PCI & Sustained thrombectomy; Standalone PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary PCI patient with ST elevation myocardial infarction
• Angiographic criteria:
• TIMI 0/1 flow at presentation
• Angiographic thrombus score ≥ 4
• Vessel diameter at site of occlusion ≥ 3.0mm (determined by coronary angiography)

You may not qualify if:

• Female participant who is pregnant or lactating
• Unconscious at presentation
• Late STEMI presentation (symptoms onset to wire time \> 12 h)
• Clinically/haemodynamically unstable patients
• Known diagnosis of severe renal disease (CKD stage 4-5)
• Suspected spontaneous coronary artery dissection
• Previous CABG
• Previous history on STEMI in the same culprit territory
• Known moderate-severe anaemia (Hb \< 9)

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford Heart Centre - John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Related Publications (3)

• Kotronias RA, Walsh JL, Andreaggi S, Portolan L, Maino A, Marin F, Chai J, Sobirov I, Sheikh M, Cahill TJ, Lucking AJ, Costello M, Fraile Moreno E, Haridas V, Shaji A, Garcia-Garcia HM, Channon KM, Banning AP, Langrish JP, De Maria GL; OxAMI and RETRIEVE AMI Investigators. Stent-Retriever Thrombectomy in STEMI With Large Thrombus Burden: The RETRIEVE AMI Randomized Trial. JACC Adv. 2025 Jul;4(7):101893. doi: 10.1016/j.jacadv.2025.101893. Epub 2025 Jun 23.

  PMID: 40555011 BACKGROUND

• Walsh JL, Kotronias RA, Banning AP, De Maria GL. Interventional thrombus modification in STEMI. Nat Rev Cardiol. 2024 Jul;21(7):435-436. doi: 10.1038/s41569-024-01020-2. No abstract available.

  PMID: 38565957 BACKGROUND

• Kotronias RA, Marin F, Emfietzoglou M, Langrish JP, Lucking AJ, Channon KM, Banning AP, De Maria GL. Rationale and Design of a Randomized Controlled Pilot Trial to Assess Stent Retriever Thrombectomy for Thrombus Burden Reduction in Patients with Acute Myocardial Infarction: The RETRIEVE-AMI Study. Cardiovasc Revasc Med. 2023 Jul;52:75-85. doi: 10.1016/j.carrev.2023.02.012. Epub 2023 Mar 6.

  PMID: 36894360 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Thrombosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Giovanni Luigi De Maria, MD

CONTACT

+44 18655 528364; GiovanniLuigi.DeMaria@ouh.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 7, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): July 8, 2027
• Study Completion (Estimated): January 8, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-06

Locations

GB (1)