RETRIEVE-AMI Study

Coronary Artery Disease Clinical Trial

— RETRIEVE-AMI  

Official title:

Stent Retriever Thrombectomy for Thrombus Burden Reduction in Patients With Acute Myocardial Infarction - RETRIEVE-AMI Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307965
• Other study ID #: 15488
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: Oxford University Hospitals NHS Trust
• Contact: Giovanni Luigi De Maria, MD PhD
• Phone: 00441865228364
• Email: GiovanniLuigi.DeMaria[@]ouh.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Heart attacks are caused by the sudden formation of a clot inside a diseased coronary artery which reduces blood flow beyond the blockage site. During conventional treatment of the blockage with what is known as a stent; a stainless steel tub that keeps the artery open, the clot that has formed is disrupted and is pushed further down leading to damage in smaller blood vessels supplying the heart muscle. This additional damage can lead to long-term heart muscle damage influencing recovery and wellbeing. The original concept that was tested to prevent this 'clot shower' was that of a suction device to withdraw the clot before stenting. However, this approach has not translated to patient benefit. Amongst the reasons put forward for the inefficacy of the suction device was that it does not remove the entire clot as it does not interact with it. A new device that physically interacts with the clot and traps it before pulling it out - the stent retriever - is now routinely used in stroke therapy to remove clots in the arteries supplying the brain. This device has been successfully used as a last resort to remove clots in a small number of heart attacks. The investigators hypothesize that stent retriever therapy will be more effective in clot removal than the current standard of care; suction or stenting. To study this, the investigators propose the RETRIEVE-AMI randomised controlled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary PCI patient with ST elevation myocardial infarction (STEMI)
• TIMI 0 flow at presentation
• Angiographic thrombus score = 4
• Vessel diameter at site of occlusion = 3.0 mm (measured by quantitative coronary angiography)

Exclusion Criteria:

• Female participant who is pregnant or lactating
• Participant with known hypersensitivity to nickel-titanium
• Unconscious at presentation
• Late presenter (pain to wire time > 6 h)
• Class Killip III/IV and/or profound bradycardia (Heart rate < 40 bpm)
• Known history of kidney failure
• Ostial occlusion
• Highly tortuous vessel
• Highly calcified vessel
• Suspected (angiographically) spontaneous coronary artery dissection
• Stent thrombosis
• Previous stent implanted proximal to the occlusion site
• Previous coronary artery bypass graft surgery (CABG)
• Previous STEMI/Transient Ischemic Attack/Stroke
• Known anaemia (Hemoglobin <9)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Thrombosis
• Thrombus

Intervention

Device:
• Retriever Thrombectomy
The SolitaireTM X revascularisation device is a self-expanding stent designed for dynamic clot integration with radiopaque markers that enhance visualisation of the optimal working length. After a thrombotic occlusion has been identified and crossed with a guidewire, the stent-retriever thrombectomy proceeds. A microcatheter (e.g., PhenomTM, MarksmanTM) is advanced over the guidewire and once it has traversed the thrombotic occlusion, the SolitaireTM X device is advanced through the microcatheter until the usable length of the stent extends past each side of the thrombus in the vessel. As the microcatheter is retracted to the proximal radiopaque marker of the stent, the stent self-expands and entangles the thrombus. The microcatheter and SolitaireTM X Revascularisation Device are withdrawn as a unit into the guide catheter under continuous aspiration. PCI then proceeds driven by clinical decision making and department guidelines.

Procedure:
• Percutaneous Coronary Intervention
Standard of care
• Thrombus Aspiration
Standard of care treatment with manual thrombectomy catheter

Locations

Country	Name	City	State
United Kingdom	Oxford Heart Centre	Oxford

Sponsors (3)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	Medtronic, Terumo Corporation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (30)

Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, McTaggart RA, Torbey MT, Kim-Tenser M, Leslie-Mazwi T, Sarraj A, Kasner SE, Ansari SA, Yeatts SD, Hamilton S, Mlynash M, Heit JJ, Zaharchuk G, Kim S, Carrozzella J, Palesch YY, Demchuk AM, Bammer R, Lavori PW, Broderick JP, Lansberg MG; DEFUSE 3 Investigators. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718. doi: 10.1056/NEJMoa1713973. Epub 2018 Jan 24. — View Citation

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Bhindi R, Kajander OA, Jolly SS, Kassam S, Lavi S, Niemela K, Fung A, Cheema AN, Meeks B, Alexopoulos D, Kocka V, Cantor WJ, Kaivosoja TP, Shestakovska O, Gao P, Stankovic G, Dzavik V, Sheth T. Culprit lesion thrombus burden after manual thrombectomy or percutaneous coronary intervention-alone in ST-segment elevation myocardial infarction: the optical coherence tomography sub-study of the TOTAL (ThrOmbecTomy versus PCI ALone) trial. Eur Heart J. 2015 Aug 1;36(29):1892-900. doi: 10.1093/eurheartj/ehv176. Epub 2015 May 20. — View Citation

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De Maria GL, Alkhalil M, Wolfrum M, Fahrni G, Borlotti A, Gaughran L, Dawkins S, Langrish JP, Lucking AJ, Choudhury RP, Porto I, Crea F, Dall'Armellina E, Channon KM, Kharbanda RK, Banning AP. Index of Microcirculatory Resistance as a Tool to Characterize Microvascular Obstruction and to Predict Infarct Size Regression in Patients With STEMI Undergoing Primary PCI. JACC Cardiovasc Imaging. 2019 May;12(5):837-848. doi: 10.1016/j.jcmg.2018.02.018. Epub 2018 Apr 18. — View Citation

De Maria GL, Patel N, Wolfrum M, Fahrni G, Kassimis G, Porto I, Dawkins S, Choudhury RP, Forfar JC, Prendergast BD, Channon KM, Kharbanda RK, Garcia-Garcia HM, Banning AP. The influence of coronary plaque morphology assessed by optical coherence tomography on final microvascular function after stenting in patients with ST-elevation myocardial infarction. Coron Artery Dis. 2017 May;28(3):198-208. doi: 10.1097/MCA.0000000000000458. — View Citation

Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11. — View Citation

Higuma T, Soeda T, Yamada M, Yokota T, Yokoyama H, Izumiyama K, Nishizaki F, Minami Y, Xing L, Yamamoto E, Lee H, Okumura K, Jang IK. Does Residual Thrombus After Aspiration Thrombectomy Affect the Outcome of Primary PCI in Patients With ST-Segment Elevation Myocardial Infarction?: An Optical Coherence Tomography Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2002-2011. doi: 10.1016/j.jcin.2016.06.050. — View Citation

Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, Kedev S, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Bernat I, Cantor WJ, Cheema AN, Steg PG, Welsh RC, Sheth T, Bertrand OF, Avezum A, Bhindi R, Natarajan MK, Horak D, Leung RC, Kassam S, Rao SV, El-Omar M, Mehta SR, Velianou JL, Pancholy S, Dzavik V; TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 2015 Oct 22. — View Citation

Jolly SS, James S, Dzavik V, Cairns JA, Mahmoud KD, Zijlstra F, Yusuf S, Olivecrona GK, Renlund H, Gao P, Lagerqvist B, Alazzoni A, Kedev S, Stankovic G, Meeks B, Frobert O. Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction: An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration. Circulation. 2017 Jan 10;135(2):143-152. doi: 10.1161/CIRCULATIONAHA.116.025371. Epub 2016 Dec 9. — View Citation

Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17. — View Citation

Kajander OA, Koistinen LS, Eskola M, Huhtala H, Bhindi R, Niemela K, Jolly SS, Sheth T; TOTAL-OCT Substudy Investigators. Feasibility and repeatability of optical coherence tomography measurements of pre-stent thrombus burden in patients with STEMI treated with primary PCI. Eur Heart J Cardiovasc Imaging. 2015 Jan;16(1):96-107. doi: 10.1093/ehjci/jeu175. Epub 2014 Sep 19. — View Citation

Kinnaird T, Kwok CS, Davies R, Calvert PA, Anderson R, Gallagher S, Sirker A, Ludman P, deBelder M, Stables R, Johnson TW, Kontopantelis E, Curzen N, Mamas M; British Cardiovascular Intervention Society and the National Institute for Cardiovascular Outcomes Research. Coronary perforation complicating percutaneous coronary intervention in patients presenting with an acute coronary syndrome: An analysis of 1013 perforation cases from the British Cardiovascular Intervention Society database. Int J Cardiol. 2020 Jan 15;299:37-42. doi: 10.1016/j.ijcard.2019.06.034. Epub 2019 Jun 14. — View Citation

Kobayashi N, Mintz GS, Witzenbichler B, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Parvataneni R, Kirtane AJ, Stone GW, Maehara A. Prevalence, Features, and Prognostic Importance of Edge Dissection After Drug-Eluting Stent Implantation: An ADAPT-DES Intravascular Ultrasound Substudy. Circ Cardiovasc Interv. 2016 Jul;9(7):e003553. doi: 10.1161/CIRCINTERVENTIONS.115.003553. — View Citation

Lagerqvist B, Frobert O, Olivecrona GK, Gudnason T, Maeng M, Alstrom P, Andersson J, Calais F, Carlsson J, Collste O, Gotberg M, Hardhammar P, Ioanes D, Kallryd A, Linder R, Lundin A, Odenstedt J, Omerovic E, Puskar V, Todt T, Zelleroth E, Ostlund O, James SK. Outcomes 1 year after thrombus aspiration for myocardial infarction. N Engl J Med. 2014 Sep 18;371(12):1111-20. doi: 10.1056/NEJMoa1405707. Epub 2014 Sep 1. — View Citation

Myint PK, Kwok CS, Roffe C, Kontopantelis E, Zaman A, Berry C, Ludman PF, de Belder MA, Mamas MA; British Cardiovascular Intervention Society and the National Institute for Cardiovascular Outcomes Research. Determinants and Outcomes of Stroke Following Percutaneous Coronary Intervention by Indication. Stroke. 2016 Jun;47(6):1500-7. doi: 10.1161/STROKEAHA.116.012700. Epub 2016 May 10. — View Citation

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Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015 Jun 11;372(24):2285-95. doi: 10.1056/NEJMoa1415061. Epub 2015 Apr 17. — View Citation

Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombus volume (mm3)	Assessed with Optical Coherence Tomography [OCT]	Pre-stent implantation during PCI
Primary	Device-related target vessel complications	Assessed with angiography and/or OCT	Pre-stent implantation during PCI
Primary	Device deficiency	Assessed with angiography and/or OCT	Pre-stent implantation during PCI
Primary	Major adverse cardiac and cerebrovascular events (MACCE)		Up to 30 days after PCI
Primary	MACCE		At 6 months after PCI
Secondary	Thrombus area (mm2)	Assessed with OCT	Pre-stent implantation during PCI
Secondary	Flow area (mm2)	Assessed with OCT	Pre-stent implantation during PCI
Secondary	Thromboatheroma area (mm2)	Assessed with OCT	Post-stent implantation during PCI
Secondary	Flow area (mm2)	Assessed with OCT	Post-stent implantation during PCI
Secondary	Stent expansion & apposition	Assessed with OCT	Post-stent implantation during PCI
Secondary	Thrombolysis in Myocardial Infarction (TIMI) flow	Assessed with angiography	Post-stent implantation during PCI
Secondary	Myocardial Blush Grade	Assessed with angiography	Post-stent implantation during PCI
Secondary	Angiography derived coronary physiology indices	Assessed with angiography	Post-stent implantation during PCI