NCT06080919

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

September 22, 2022

Last Update Submit

October 18, 2023

Conditions

Percutaneous Coronary InterventionCoronary Artery DiseaseDrug Coated-balloonIntravascular UltrasoundPlaque ModificationMicrovascular Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Change in percentage atheroma volume evaluated by intravascular ultrasound (IVUS) from baseline at 3 month follow-up.

    Baseline to 3 month follow-up.

Secondary Outcomes (4)

  • Percentage of minimum lumen change baseline to 3 month follow-up.

    Baseline to 3 month follow-up.

  • Percentage of plaque burden change baseline to 3 month follow-up.

    Baseline to 3 month follow-up.

  • Rate of IMRangio change from baseline to post DCB-PCI

    Baseline to post DCB-PCI

  • Rate of IMRangio change from post DCB-PCI to 3 month follow-up

    Post DCB-PCI to 3 month follow-up

Study Arms (1)

DCB-PCI

EXPERIMENTAL

Patients with coronary artery disease undergoing percutaneous coronary intervention will undergo DCB-PCI under IVUS guidance and angio-derived coronary phisiology assessment. Angiographic follow-up with IVUS evaluation will be performed 3 months after the index procedure.

Device: Drug coated-balloon percutaneous coronary intervention.Device: Angiography-derived coronary physiology (IMRangio)

Interventions

Drug coated-balloon percutaneous coronary intervention.DEVICE

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.

DCB-PCI
Angiography-derived coronary physiology (IMRangio)DEVICE

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

DCB-PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with coronary artery disease undergoing percutaneous coronary intervention with DCB.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 32597391BACKGROUND

  • 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.

    PMID: 30165437BACKGROUND

  • 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.

    PMID: 32473887BACKGROUND

  • 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.

    PMID: 32592437BACKGROUND

  • 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.

    PMID: 33224762BACKGROUND

  • Sorolla Romero JA, Teira Calderon A, Vilchez Tschischke JP, Aguar Carrascosa P, Ten Morro F, Andres Lalaguna L, Martinez Dolz L, Diez Gil JL, Garcia-Garcia HM, Sanz Sanchez J. [Plaque modification and impact on the microcirculation territory after drug-coated balloon angioplasty. The PLAMI study design]. REC Interv Cardiol. 2024 Mar 4;6(2):83-88. doi: 10.24875/RECIC.M23000438. eCollection 2024 Apr-Jun.

    PMID: 40416350DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Jorge Sanz Sanchez, MD, PhD

CONTACT

440087sjorge4@gmx.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study will be an investigator-initiated, single-arm, open-label, pilot study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2022

First Posted

October 12, 2023

Study Start

September 12, 2022

Primary Completion

February 1, 2024

Study Completion

May 1, 2024

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

ES(1)