DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
NCT ID: NCT06657833
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2024-12-17
2027-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Drug Eluting Balloon (DEB)
Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon
Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon
Drug Eluting Stent (DES)
Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
Interventions
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Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon
Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon
Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
Eligibility Criteria
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Inclusion Criteria
* Severe coronary lesion with calcified nodule, confirmed with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and;
* Lesion to treat in a vessel between 2.5 and 4 mm.
Exclusion Criteria
* Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.
* Pregnant or breastfeeding patients.
* Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.
* Impossibility to maintain double antiplatelet treatment during at least 1 month.
* Life expectancy \<1 year.
* Index lesion at left main stem.
* Aorto-ostial lesion.
* Target lesion previously treated with stents or DEB.
* High thrombus burden in the target lesion (TIMI thrombus scale≥3).
18 Years
ALL
No
Sponsors
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Fundación EPIC
OTHER
Responsible Party
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Locations
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Hospital Del Mar
Barcelona, , Spain
Hospital Universitario de La Paz
Fuencarral-El Pardo, , Spain
Hospital Universitario de Galdakao-Usansolo
Galdakao, , Spain
Hospital Universitario de León
León, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Clínico San Carlos
Moncloa-Aravaca, , Spain
Hospital Universitario de Navarra
Pamplona, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hospital Universitario de Vigo
Vigo, , Spain
Countries
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Central Contacts
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References
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Jurado-Román A, Gómez-Menchero A, Gonzalo N, et al. Plaque modification techniques to treat calcified coronary lesions. Position paper from the ACI-SEC. REC Interv Cardiol Engl Ed. Published online February 7, 2023:9672. doi:10.24875/RECICE.M22000345
Morofuji T, Kuramitsu S, Shinozaki T, Jinnouchi H, Sonoda S, Domei T, Hyodo M, Shirai S, Ando K. Clinical impact of calcified nodule in patients with heavily calcified lesions requiring rotational atherectomy. Catheter Cardiovasc Interv. 2021 Jan 1;97(1):10-19. doi: 10.1002/ccd.28896. Epub 2020 Apr 7.
Lee T, Mintz GS, Matsumura M, Zhang W, Cao Y, Usui E, Kanaji Y, Murai T, Yonetsu T, Kakuta T, Maehara A. Prevalence, Predictors, and Clinical Presentation of a Calcified Nodule as Assessed by Optical Coherence Tomography. JACC Cardiovasc Imaging. 2017 Aug;10(8):883-891. doi: 10.1016/j.jcmg.2017.05.013.
Sato T, Matsumura M, Yamamoto K, Shlofmitz E, Moses JW, Khalique OK, Thomas SV, Tsoulios A, Cohen DJ, Mintz GS, Shlofmitz RA, Jeremias A, Ali ZA, Maehara A. Impact of Eruptive vs Noneruptive Calcified Nodule Morphology on Acute and Long-Term Outcomes After Stenting. JACC Cardiovasc Interv. 2023 May 8;16(9):1024-1035. doi: 10.1016/j.jcin.2023.03.009.
Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
Ho HH, Lee JH, Khoo DZL, Hpone KKS, Li KFC. Shockwave intravascular lithotripsy and drug-coated balloon angioplasty in calcified coronary arteries: preliminary experience in two cases. J Geriatr Cardiol. 2021 Aug 28;18(8):689-691. doi: 10.11909/j.issn.1671-5411.2021.08.009. No abstract available.
Iwasaki Y, Koike J, Ko T, Funatsu A, Kobayashi T, Ikeda T, Nakamura S. Comparison of drug-eluting stents vs. drug-coated balloon after rotational atherectomy for severely calcified lesions of nonsmall vessels. Heart Vessels. 2021 Feb;36(2):189-199. doi: 10.1007/s00380-020-01684-z. Epub 2020 Aug 28.
Other Identifiers
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EPIC40-DEBSCAN-IVL
Identifier Type: -
Identifier Source: org_study_id
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