Clinical trial NCT06657833: DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
Official title: DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Calcified Nodules
Calcified lesions
Drug eluting balloon
Drug eluting stent
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).

Detailed description: Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.

Eligibility criteria: Inclusion Criteria:

Patients must meet all inclusion criteria:

* Patients \>18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and
* Severe coronary lesion with a calcified nodule (highly recommended confirmation with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and
* Lesion to treat in a vessel between 2.5 and 4 mm

Exclusion Criteria:

Patients must not meet any criteria

* Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.
* Pregnant 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).

Primary outcomes:
measure: EFFICACY: Late Lumen Loss (LLL)
timeFrame: 6 Month
measure: EFFICACY: Net Lumen Gain (NLG)
timeFrame: 6 Month
Secondary outcomes:
measure: SAFETY: Dissection
timeFrame: During Percutaneous Coronary Intervention (PCI)
measure: SAFETY: Perforation
timeFrame: During Percutaneous Coronary Intervention (PCI)
measure: SAFETY: Abrupt vessel closure
timeFrame: During Percutaneous Coronary Intervention (PCI)
measure: SAFETY: Slow Flow
timeFrame: During Percutaneous Coronary Intervention (PCI)
measure: SAFETY: No Reflow
timeFrame: During Percutaneous Coronary Intervention (PCI)
measure: SAFETY: Thrombosis
timeFrame: During Percutaneous Coronary Intervention (PCI)
measure: SAFETY: MACE
timeFrame: Up to 30 days
measure: SAFETY: Stent Thrombosis
timeFrame: During hospitalization
measure: SAFETY: Major bleeding event
timeFrame: During hospitalization
measure: SAFETY: Stent Thrombosis
timeFrame: During hospitalization
measure: SAFETY: Hemodynamic stability
timeFrame: During hospitalization
measure: EFFICACY: Minimal Lumen Diameter (MLD)
timeFrame: Day 0
measure: EFFICACY: Diameter Stenosis
timeFrame: Day 0
measure: EFFICACY: Minimal Lumen Diameter (MLD)
timeFrame: 6 Months
measure: EFFICACY: Minimal Lumen Diammeter (MLD)
timeFrame: 12 Months
measure: EFFICACY: Binary reestenosis
timeFrame: 6 Months
measure: EFFICACY: Crossover rate
timeFrame: Day 0
measure: SAFETY: MACE
timeFrame: 6 Months
measure: SAFETY: MACE
timeFrame: 12 Months
measure: SAFETY: MACE
timeFrame: 24 Months
measure: SAFETY: Myocardial Infarction
timeFrame: 6 Months
measure: SAFETY: Myocardial Infarction
timeFrame: 12 Months
measure: SAFETY: Myocardial Infarction
timeFrame: 24 Months
measure: SAFETY: Cardiac death
timeFrame: 12 Months
measure: SAFETY: Cardiac death
timeFrame: 24 Months
measure: SAFETY: Target Lesion Revascularization.
timeFrame: 6 Months
measure: SAFETY: Target Lesion Revascularization.
timeFrame: 12 Months
measure: SAFETY: Target Lesion Revascularization.
timeFrame: 24 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Fuencarral-El Pardo
country: Spain
facility: Hospital Universitario de La Paz
city: Galdakao
country: Spain
facility: Hospital Universitario de Galdakao-Usansolo
city: León
country: Spain
facility: Hospital Universitario de León
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Vigo
country: Spain
facility: Hospital Universitario de Vigo
Study officials:
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.