STEMI - ST Elevation Myocardial InfarctionPhase 2/3CAPTURE AMINCT07687576
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
A Phase 2/3 study testing Sustained thrombectomy and Percutaneous Coronary Intervention in people with STEMI - ST Elevation Myocardial Infarction, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Sustained thrombectomy and Percutaneous Coronary Intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jul 2026to 8 Jan 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Previous CABG
- Previous history on STEMI in the same culprit territory
- Known moderate-severe anaemia (Hb < 9)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Heart Centre - John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
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:
- 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.
- Being tested
- Sustained thrombectomy, Percutaneous Coronary Intervention
- Keywords
- Thrombus, Thrombectomy, Optical Coherence Tomography, Microvascular Injury
- Medical subject headings
- ST Elevation Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained thrombectomyDevice
Sustained thrombectomy with the Indigo® System CAT™ RX aspiration catheter
Percutaneous Coronary InterventionProcedure or surgery
Optical Coherence Tomography guided Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| Standalone PCI | Active comparator | Standalone OCT guided PCI Receives: Procedure: Percutaneous Coronary Intervention |
| PCI & Sustained thrombectomy | Experimental | OCT guided PCI \& Sustained Thrombectomy Receives: Device: Sustained thrombectomy; Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre stent Thrombus Burden
Pre stent Thrombus Burden (thrombus volume/lumen volume) evaluated by Optical Coherence Tomography
Measured: Pre stent implantation (Periprocedural)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start8 Jul 2026
- Primary completion8 Jul 2027 (estimated)
- Study completion8 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Luigi De Maria, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687576
- Sponsor's protocol ID
- 19672
- Acronym
- CAPTURE AMI
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40555011Walsh 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.
PubMed 38565957Kotronias 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.
PubMed 36894360Snir AD, Kotronias RA, Cascone A, Andreaggi S, Shabbir A, Langrish JP, Banning AP, De Maria GL. Rationale and design of a randomized controlled trial to evaluate thrombus modification efficacy of sustained mechanical aspiration thrombectomy in patients with ST Elevation Myocardial Infarction: The CAPTURE AMI study. Cardiovasc Revasc Med. 2026 Oct 7:S1553-8389(26)00399-4. doi: 10.1016/j.carrev.2026.10.002. Online ahead of print.
PubMed 42875324
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07687576
- Acronym / sponsor ID
- CAPTURE AMI / 19672
- Keywords
- Thrombus, Thrombectomy, Optical Coherence Tomography, Microvascular Injury
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 8 Jul 2027 (estimated)
- Study completion
- 8 Jan 2028 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standalone PCI | Active comparator | Procedure: Percutaneous Coronary InterventionStandalone OCT guided PCI |
| PCI & Sustained thrombectomy | Experimental | Device: Sustained thrombectomy, Procedure: Percutaneous Coronary InterventionOCT guided PCI \& Sustained Thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary PCI patient with ST elevation myocardial infarction
- Angiographic criteria:
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained thrombectomySustained thrombectomy with the Indigo® System CAT™ RX aspiration catheter | Device | PCI & Sustained thrombectomy |
| Percutaneous Coronary InterventionOptical Coherence Tomography guided Percutaneous Coronary Intervention | Procedure or surgery | PCI & Sustained thrombectomy, Standalone PCI |
Primary outcome
Pre stent Thrombus Burden
Time frame: Pre stent implantation (Periprocedural)
Pre stent Thrombus Burden (thrombus volume/lumen volume) evaluated by Optical Coherence Tomography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 40555011Kotronias 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.
- Background: PubMed 38565957Walsh 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.
- Background: PubMed 36894360Kotronias 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.
- Derived from this study: PubMed 42875324Snir AD, Kotronias RA, Cascone A, Andreaggi S, Shabbir A, Langrish JP, Banning AP, De Maria GL. Rationale and design of a randomized controlled trial to evaluate thrombus modification efficacy of sustained mechanical aspiration thrombectomy in patients with ST Elevation Myocardial Infarction: The CAPTURE AMI study. Cardiovasc Revasc Med. 2026 Oct 7:S1553-8389(26)00399-4. doi: 10.1016/j.carrev.2026.10.002. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sustained thrombectomy and Percutaneous Coronary Intervention in people with STEMI - ST Elevation Myocardial Infarction, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Luigi De Maria, MD (+44 18655 528364, GiovanniLuigi.DeMaria@ouh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre stent Thrombus Burden (time frame: Pre stent implantation (Periprocedural)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07687576, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.