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The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.
The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consecutive patients with stent underexpantsion treated with IVL |
| ||
| Consecutive patients with stent underexpantsion treated ELCA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent Underexpansion | Device | Stent underexpansion was diagnosed as stent expansion of <80% assessed with intravascular imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint was device success | Technical success with a final stent expansion ≥80%. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device-oriented composite endpoint (DOCE) | cardiac death, target lesion revascularization, or target vessel myocardial infarction | Thirty days |
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Stent underexpansion as stent expansion of <80% assessed with intravascular imaging (minimum in-stent lumen area divided by average reference lumen area x100%).
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Patients with underexpanded coronary stent were included regardless of time since stent implantation. Patients who did not undergo intravasuclar imaging during PCI were excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital | Florence | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35407387 | Background | Wanha W, Tomaniak M, Wanczura P, Bil J, Januszek R, Wolny R, Opolski MP, Kuzma L, Janas A, Figatowski T, Gasior P, Milewski M, Roleder-Dylewska M, Lewicki L, Kulczycki J, Wlodarczak A, Tomasiewicz B, Iwanczyk S, Sacha J, Koltowski L, Dziarmaga M, Jaguszewski M, Kralisz P, Olajossy B, Sobieszek G, Dyrbus K, Lebek M, Smolka G, Reczuch K, Gil RJ, Dobrzycki S, Kwiatkowski P, Rogala M, Gasior M, Ochala A, Kochman J, Witkowski A, Lesiak M, D'Ascenzo F, Bartus S, Wojakowski W. Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry. J Clin Med. 2022 Mar 23;11(7):1779. doi: 10.3390/jcm11071779. |
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| Fabrizio D'Ascenzo | Turin | Italy |
| Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital | Bialystok | Poland |
| First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland | Gdansk | Poland |
| Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland | Katowice | 40-635 | Poland |
| Jacek Legutko | Krakow | Poland |
| Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland | Krakow | Poland |
| 1st Military Hospital in Lublin, Lublin, Poland | Lubin | Poland |
| Department of Cardiology, Copper Health Centre (MCZ) | Lubin | Poland |
| Clinical Department of Interventional Cardiology, Medical University of Lublin | Lublin | Poland |
| Department of Cardiology, University Hospital, Institute of Medical Sciences | Opole | Poland |
| Department of Cardiology, Poznan University of Medical Sciences | Poznan | Poland |
| Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow | Rzeszów | Poland |
| 1st Department of Cardiology, Medical University of Warsaw | Warsaw | Poland |
| Department of Cardiology and Internal Diseases, Military Institute of Medicine | Warsaw | Poland |
| Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland | Warsaw | Poland |
| Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration | Warsaw | Poland |
| Department of Invasive Cardiology, Wejherowo | Wejherowo | Poland |
| Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University | Wroclaw | Poland |
| Third Department of Cardiology, Medical University of Katowice | Zabrze | Poland |