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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06080919
Other study ID # 523
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 12, 2022
Est. completion date May 2024

Study information

Verified date October 2023
Source Hospital Universitario La Fe
Contact Jorge Sanz Sanchez, MD, PhD
Phone 440087
Email sjorge4@gmx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Coronary artery disease (CAD) is one of the most common causes of mortality worldwide. Despite drug eluting stents (DES) are the most common treatment strategy, drug-coated balloons (DCB) represent an appealing alternative to DES as they eliminate the risk of stent thrombosis and do not leave any type of metallic structure in the vessel wall. However, the evidence of the vessel wall healing processes, plaque remodeling, plaque composition and impact on coronary microcirculation after PCI with DCB have not yet been characterized. The purpose of this study is to assess the changes in percentage atheroma volume evaluated by intravascular ultrasound (IVUS) in patients undergoing DCB-PCI.


Description:

The study will be an investigator-initiated, single-arm, open-label, pilot study in patients undergoing PCI with DCB for the novo lesion. Because of the exploratory nature of this study, no formal sample size calculation is required. On the basis of previous pilot studies with similar designs, a sample of 30 lesions is planned to be evaluated. After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Patients will go DCB-PCI. IVUS will be evaluated prior to PCI-DCB, immediately after and at 3-month follow-up. Angiography-derived coronary physiology will be assessed after the procedure using Angio Plus software (Pulse Medical Imaging Technology, Shanghai, China). The angiography images will be used to obtain the IMRangio values, prior, post to DCB-PCI and 3 month follow-up.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with coronary artery disease undergoing percutaneous coronary intervention with DCB. Exclusion Criteria: - Aged < 18 years. - Cardiogenic shock. - ST-segment elevation myocardial infarction. - Use of mechanical circulatory support. - Chronic total occlusions, bifurcation lesions, left main coronary artery disease, severe calcified lesions, graft interventions and in-stent restenosis. - Inability to provide informed consent. - Unable to understand and follow study-related instructions or unable to comply with study protocol. - Currently participating in another trial. - Pregnant women.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Drug coated-balloon percutaneous coronary intervention.
Patients will undergo DCB-PCI under IVUS guidance (OpticrossTMHD 60 MHz). Target lesion will be predilated with semi-compliant balloons or non-compliant balloons.The lesion will be then treated with DCB with a reference vessel diameter/balloon diameter ratio of 1.
Angiography-derived coronary physiology (IMRangio)
Angiography-derived coronary physiology will be assessed after the procedure using Angio Plus software (Pulse Medical Imaging Technology, Shanghai, China). The angiography images will be used to obtain the IMRangio values, prior and post to DCB-PCI

Locations

Country Name City State
Spain Hospital Universitario y Politécnico La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27. — View Citation

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096. — View Citation

Sanz Sanchez J, Chiarito M, Cortese B, Moretti A, Pagnotta P, Reimers B, Stefanini GG, Ferrante G. Drug-Coated balloons vs drug-eluting stents for the treatment of small coronary artery disease: A meta-analysis of randomized trials. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):66-75. doi: 10.1002/ccd.29111. Epub 2020 Jun 27. — View Citation

Stefanini GG, Alfonso F, Barbato E, Byrne RA, Capodanno D, Colleran R, Escaned J, Giacoppo D, Kunadian V, Lansky A, Mehilli J, Neumann FJ, Regazzoli D, Sanz-Sanchez J, Wijns W, Baumbach A. Management of myocardial revascularisation failure: an expert consensus document of the EAPCI. EuroIntervention. 2020 Dec 4;16(11):e875-e890. doi: 10.4244/EIJ-D-20-00487. — View Citation

Xu J, Lo S. Fundamentals and role of intravascular ultrasound in percutaneous coronary intervention. Cardiovasc Diagn Ther. 2020 Oct;10(5):1358-1370. doi: 10.21037/cdt.2020.01.15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in percentage atheroma volume evaluated by intravascular ultrasound (IVUS) from baseline at 3 month follow-up. Baseline to 3 month follow-up.
Secondary Percentage of minimum lumen change baseline to 3 month follow-up. Baseline to 3 month follow-up.
Secondary Percentage of plaque burden change baseline to 3 month follow-up. Baseline to 3 month follow-up.
Secondary Rate of IMRangio change from baseline to post DCB-PCI Baseline to post DCB-PCI
Secondary Rate of IMRangio change from post DCB-PCI to 3 month follow-up Post DCB-PCI to 3 month follow-up
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