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Coronary Artery DiseasePLAMINCT06080919

Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI).

A study testing Drug coated-balloon percutaneous coronary intervention. and Angiography-derived coronary physiology (IMRangio) in people with Coronary Artery Disease and Drug Coated-balloon, run by Hospital Universitario La Fe at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Drug coated-balloon percutaneous coronary intervention. and Angiography-derived coronary physiology (IMRangio)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
12 Sep 2022to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • Unable to understand and follow study-related instructions or unable to comply with study protocol.
  • Currently participating in another trial.
  • Pregnant women.

Trial locations and contacts

1 site in 1 country.

Jorge Sanz Sanchez, MD, PhD contact

440087

sjorge4@gmx.com

Spain1 site, 1 recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

    Jorge Sanz Sanchez, MD, PhD, 440087, sjorge4@gmx.com

    Jose Luis Diez Gil, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention.

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.

Read the detailed 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.

Being tested
Drug coated-balloon percutaneous coronary intervention., Angiography-derived coronary physiology (IMRangio)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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

Study groups in NCT06080919
Study groupRoleWhat they receive
DCB-PCIExperimentalPatients 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.
Receives: Device: Drug coated-balloon percutaneous coronary intervention.; Device: Angiography-derived coronary physiology (IMRangio)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline to 3 month follow-up.

Secondary outcomes (4)

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

    Measured: Baseline to 3 month follow-up.

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

    Measured: Baseline to 3 month follow-up.

  3. Rate of IMRangio change from baseline to post DCB-PCI

    Measured: Baseline to post DCB-PCI

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

    Measured: Post DCB-PCI to 3 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start12 Sep 2022
  3. Primary completionFeb 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study will be an investigator-initiated, single-arm, open-label, pilot study.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06080919
Sponsor's protocol ID
523
Acronym
PLAMI
Status last verified
Oct 2023
First submitted
22 Sep 2022
Last updated
23 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data would be shared under appropriate request

Publications

  • 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.

    PubMed 32597391

  • 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.

    PubMed 30165437

  • 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.

    PubMed 32473887

  • 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.

    PubMed 32592437

  • 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.

    PubMed 33224762

  • 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/RECICE.M23000436. eCollection 2024 Apr-Jun.

    PubMed 40416350

Questions about this trial

What is this clinical trial studying?

A study testing Drug coated-balloon percutaneous coronary intervention. and Angiography-derived coronary physiology (IMRangio) in people with Coronary Artery Disease and Drug Coated-balloon, run by Hospital Universitario La Fe at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jorge Sanz Sanchez, MD, PhD (440087, sjorge4@gmx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in percentage atheroma volume evaluated by intravascular ultrasound (IVUS) from baseline at 3 month follow-up. (time frame: Baseline to 3 month follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06080919, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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