DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.

NCT06657833 | Recruiting DMC

• 1 other identifier: EPIC40-DEBSCAN-IVL
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 12

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).

Conditions

Coronary Artery Disease

Keywords

Calcified Nodules; Calcified lesions; Drug eluting balloon; Drug eluting stent

Outcome Measures

Primary Outcomes (2)

• EFFICACY: Late Lumen Loss (LLL)

  Late lumen loss (LLL, expressed in mm) measured within the treated segment by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter (MLD) at the end of the interventional procedure and MLD at 9-month follow-up

  9 Month

• EFFICACY: Net Lumen Gain (NLG)

  Net lumen gain (NLG, expressed in mm) measured by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter within the treated segment (MLD) at 9-month follow-up and MLD at the lesion site at baseline

  9 Month

Secondary Outcomes (28)

• SAFETY: Dissection

  During Percutaneous Coronary Intervention (PCI)

• SAFETY: Perforation

  During Percutaneous Coronary Intervention (PCI)

• SAFETY: Abrupt vessel closure

  During Percutaneous Coronary Intervention (PCI)

• SAFETY: Slow Flow

  During Percutaneous Coronary Intervention (PCI)

• SAFETY: No Reflow

  During Percutaneous Coronary Intervention (PCI)

Study Arms (2)

Drug Eluting Balloon (DEB)

OTHER

Device: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon

Drug Eluting Stent (DES)

OTHER

Device: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent

Interventions

Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon DEVICE

Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon

Drug Eluting Balloon (DEB)

Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent DEVICE

Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent

Drug Eluting Stent (DES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (12)

Hospital Del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Universitario de La Paz

Fuencarral-El Pardo, 28046, Spain

RECRUITING

Hospital Universitario de Galdakao-Usansolo

Galdakao, 48960, Spain

RECRUITING

Hospital Universitario de León

León, 24008, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

RECRUITING

Hospital Clínico San Carlos

Moncloa-Aravaca, 28040, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, 31008, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, 46014, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Hospital Universitario de Vigo

Vigo, 36312, Spain

RECRUITING

Related Publications (7)

• 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

  BACKGROUND

• 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.

  PMID: 32259392 BACKGROUND

• 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.

  PMID: 28797410 BACKGROUND

• 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.

  PMID: 37164599 BACKGROUND

• 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.

  PMID: 31553205 BACKGROUND

• 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.

  PMID: 34527034 BACKGROUND

• 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.

  PMID: 32857188 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

FUNDACION EPIC

CONTACT

0034987225638; iepic@fundacionepic.org

ALFONSO JURADO ROMAN, MD,PhD

CONTACT

alfonsojuradoroman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 26, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

ES (12)