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| Name | Class |
|---|---|
| Shockwave Medical, Inc. | INDUSTRY |
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multicenter, international, all-comers registry aims to provide insights in the current application of IVL technology in patients with calcified coronary lesions undergoing PCI using IVL technology.
The primary objectives are:
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVL cohort | Patients with calcific CAD undergoing PCI and treated with IVL, irrespectively of the clinical indication (stable angina, acute coronary syndrome), anatomical scenario (de novo coronary stenosis, in-stent restenosis, etc) and/or concomitant use of other debulking techniques |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI with use of IVL | Device | Use of IVL for the treatment of calcific coronary artery lesions at operator's discretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| procedural success | success in facilitating stent delivery with <30% residual stenosis and without in-hospital MACE | Periprocedurally and from hospital admission to discharge (an average of 2 days) |
| cumulative hierarchical incidence of MACE | cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR) at 30-days following the index procedure | At 30 days follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| rate of MACE at 3 months | rate of MACE at 3-months following the index procedure | At 3 months follow-up |
| rate of MACE at 6 months | rate of MACE at 6-months following the index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients with calcific CAD undergoing PCI and treated with IVL, irrespectively of the clinical indication (stable angina, acute coronary syndrome), anatomical scenario (de novo coronary stenosis, in-stent restenosis due to poorly stent expansion) and/or concomitant use of other debulking techniques (e.g. RA).
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| Name | Affiliation | Role |
|---|---|---|
| José M Montero Cabezas, MD PhD | Leiden University Medical Center | Study Chair |
| Ibtihal Al Amri, MD PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | ||||
| Red Cross Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34973904 | Background | Kawashima H, Serruys PW, Hara H, Ono M, Gao C, Wang R, Garg S, Sharif F, de Winter RJ, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification. JACC Cardiovasc Interv. 2022 Jan 24;15(2):193-204. doi: 10.1016/j.jcin.2021.10.026. Epub 2021 Dec 29. | |
| 36453826 |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| At 6 months follow-up |
| rate of MACE at 12 months | rate of MACE at 12-months following the index procedure | At 12 months follow-up |
| the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis | at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure | 30-days, 3-, 6- and 12-months |
| the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis | at any time point, any type of angina at 30-days follow-up | at 30-days follow-up |
| the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis | at any time point, any type of angina at 3 months follow-up | at 3 months follow-up |
| the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis | at any time point, any type of angina at 6 months follow-up | at 6 months follow-up |
| the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis | at any time point, any type of angina at 12-months follow-up | at 12-months follow-up |
| Athens |
| Greece |
| Amsterdam University Medical Center | Amsterdam | North Holland | Netherlands |
| Leiden University Medical Center | Leiden | South Holland | 2333ZA | Netherlands |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands |
| Rijnstate Ziekenhuis | Arnhem | Netherlands |
| Medisch Centrum Leeuwaarden | Leeuwarden | Netherlands |
| Radboud University Medical Center | Nijmegen | Netherlands |
| Background |
| Rheude T, Koch T, Joner M, Lenz T, Xhepa E, Wiebe J, Coughlan JJ, Aytekin A, Cassese S, Laugwitz KL, Schunkert H, Kastrati A, Kufner S. Ten-year clinical outcomes of drug-eluting stents with different polymer coating strategies by degree of coronary calcification: a pooled analysis of the ISAR-TEST 4 and 5 randomised trials. EuroIntervention. 2023 Feb 20;18(14):1188-1196. doi: 10.4244/EIJ-D-22-00781. |
| 26301561 | Background | Lee MS, Shah N. The Impact and Pathophysiologic Consequences of Coronary Artery Calcium Deposition in Percutaneous Coronary Interventions. J Invasive Cardiol. 2016 Apr;28(4):160-7. Epub 2015 Aug 25. |
| 24530667 | Background | Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Genereux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014 May 6;63(17):1703-14. doi: 10.1016/j.jacc.2014.01.017. Epub 2014 Feb 12. |
| 25882575 | Background | Mintz GS. Intravascular imaging of coronary calcification and its clinical implications. JACC Cardiovasc Imaging. 2015 Apr;8(4):461-471. doi: 10.1016/j.jcmg.2015.02.003. |
| 30711477 | Background | Kassimis G, Raina T, Kontogiannis N, Patri G, Abramik J, Zaphiriou A, Banning AP. How Should We Treat Heavily Calcified Coronary Artery Disease in Contemporary Practice? From Atherectomy to Intravascular Lithotripsy. Cardiovasc Revasc Med. 2019 Dec;20(12):1172-1183. doi: 10.1016/j.carrev.2019.01.010. Epub 2019 Jan 10. |
| 37208199 | Background | Barbato E, Gallinoro E, Abdel-Wahab M, Andreini D, Carrie D, Di Mario C, Dudek D, Escaned J, Fajadet J, Guagliumi G, Hill J, McEntegart M, Mashayekhi K, Mezilis N, Onuma Y, Reczuch K, Shlofmitz R, Stefanini G, Tarantini G, Toth GG, Vaquerizo B, Wijns W, Ribichini FL. Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group. Eur Heart J. 2023 Nov 1;44(41):4340-4356. doi: 10.1093/eurheartj/ehad342. |
| 33069849 | Background | Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15. |
| 31867065 | Background | Forero MNT, Daemen J. The Coronary Intravascular Lithotripsy System. Interv Cardiol. 2019 Nov 18;14(3):174-181. doi: 10.15420/icr.2019.18.R1. eCollection 2019 Nov. |
| 33939604 | Background | Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3. |
| 28797412 | Background | Ali ZA, Brinton TJ, Hill JM, Maehara A, Matsumura M, Karimi Galougahi K, Illindala U, Gotberg M, Whitbourn R, Van Mieghem N, Meredith IT, Di Mario C, Fajadet J. Optical Coherence Tomography Characterization of Coronary Lithoplasty for Treatment of Calcified Lesions: First Description. JACC Cardiovasc Imaging. 2017 Aug;10(8):897-906. doi: 10.1016/j.jcmg.2017.05.012. |
| 19758907 | Background | Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, van den Brand M, Van Dyck N, Russell ME, Mohr FW, Serruys PW. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention. 2005 Aug;1(2):219-27. No abstract available. |
| 7895353 | Background | Mintz GS, Popma JJ, Pichard AD, Kent KM, Satler LF, Chuang YC, Ditrano CJ, Leon MB. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995 Apr 1;91(7):1959-65. doi: 10.1161/01.cir.91.7.1959. |
| 22421299 | Background | Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Raber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079. |
| 31504439 | Background | Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available. |
| 26628592 | Background | Bass TA. High-Risk Percutaneous Coronary Interventions in Modern Day Clinical Practice: Current Concepts and Challenges. Circ Cardiovasc Interv. 2015 Dec;8(12):e003405. doi: 10.1161/CIRCINTERVENTIONS.115.003405. No abstract available. |
| 36120480 | Background | Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, Nakamura S, Shibata Y; Disrupt CAD IV Investigators. Intravascular Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stent Placement - Japanese Disrupt CAD IV Study 1-Year Results. Circ Rep. 2022 Aug 20;4(9):399-404. doi: 10.1253/circrep.CR-22-0068. eCollection 2022 Sep 9. |
| 23266232 | Background | Abdel-Wahab M, Richardt G, Joachim Buttner H, Toelg R, Geist V, Meinertz T, Schofer J, King L, Neumann FJ, Khattab AA. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013 Jan;6(1):10-9. doi: 10.1016/j.jcin.2012.07.017. Epub 2012 Dec 19. |
| 37182254 | Background | Sardella G, Stefanini G, Leone PP, Boccuzzi G, Fovero NT, Van Mieghem N, Giacchi G, Escaned J, Fineschi M, Testa L, Valenti R, Di Mario C, Briguori C, Cortese B, Ribichini F, Oreglia JA, Colombo A, Sangiorgi G, Barbato E, Sonck J, Ugo F, Trani C, Castriota F, Paggi A, Porto I, Tomai F, Mancone M. Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry. Am J Cardiol. 2023 Jul 1;198:1-8. doi: 10.1016/j.amjcard.2023.04.032. Epub 2023 May 12. |
| 36336588 | Background | Mousa MAA, Bingen BO, Al Amri I, Mertens BJA, Taha S, Tohamy A, Youssef A, Jukema JW, Montero-Cabezas JM. Efficacy and Safety of Intravascular Lithotripsy Versus Rotational Atherectomy in Balloon-Crossable Heavily Calcified Coronary Lesions. Cardiovasc Revasc Med. 2023 Mar;48:1-6. doi: 10.1016/j.carrev.2022.10.011. Epub 2022 Oct 29. No abstract available. |
| 38385926 | Background | Rodriguez-Leor O, Cid-Alvarez AB, Lopez-Benito M, Gonzalo N, Vilalta V, Diarte de Miguel JA, Lopez LF, Jurado-Roman A, Diego A, Oteo JF, Cuellas C, Trillo R, Travieso A, Alfonso F, Carrillo X, Vegas-Valle JM, Cortes-Villar C, Pascual I, Munoz Camacho JF, Flores X, Vera-Vera S, Moreu J, Barreira de Sousa G, Marti D, Jimenez-Mazuecos J, Fuertes M, Ocaranza R, de la Torre Hernandez JM, Lozano F, Solana Martinez SG, Gomez-Lara J, Perez de Prado A; REPLICA-EPIC18 Investigators. A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):756-767. doi: 10.1016/j.jcin.2023.12.018. Epub 2024 Feb 21. |
| 40686682 | Derived | Oliveri F, Garcia PV, van Oort MJH, Phagu A, Al Amri I, Bingen BO, Paradies V, Mincione G, Claessen BE, Dimitriu-Leen AC, Kefer J, Girgis H, Vossenberg T, Mandurino-Mirizzi A, Van der Kley F, Jukema JW, Montero-Cabezas JM. Intravascular lithotripsy for the treatment of calcified coronary lesions in individuals of advanced age: a post-hoc analysis of the multicentre, prospective BENELUX-IVL study. EClinicalMedicine. 2025 Jul 4;85:103342. doi: 10.1016/j.eclinm.2025.103342. eCollection 2025 Jul. |
| 40551528 | Derived | Oliveri F, D'Acunto G, Oort MJHV, Phagu A, Amri IA, Bingen BO, Paradies V, Mincione G, Claessen BE, Dimitriu-Leen AC, Kefer J, Girgis H, Vossenberg T, Van der Kley F, Jukema JW, Montero-Cabezas JM. Intravascular Lithotripsy for Calcific Coronary Bifurcations: Procedural Success and 1-Year Clinical Outcomes. Catheter Cardiovasc Interv. 2025 Aug;106(2):1489-1498. doi: 10.1002/ccd.31713. Epub 2025 Jun 23. |
| 40038885 | Derived | van Oort MJH, Bingen BO, Oliveri F, Al Amri I, Phagu AAS, Claessen BEPM, Dimitriu-Leen AC, Vossenberg TN, Kefer J, Girgis H, van der Kley F, Jukema JW, Montero-Cabezas JM. Clinical and Technical Predictors of Treatment Success After Coronary Intravascular Lithotripsy in Calcific Coronary Lesions. Catheter Cardiovasc Interv. 2025 May;105(6):1418-1426. doi: 10.1002/ccd.31480. Epub 2025 Mar 4. |
| D019060 | Minimally Invasive Surgical Procedures |