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

October 18, 2023 updated by: Jorge Sanz Sanchez, Hospital Universitario La Fe

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jorge Sanz Sanchez, MD, PhD
  • Phone Number: 440087
  • Email: sjorge4@gmx.com

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politecnico La Fe
        • Contact:
        • Sub-Investigator:
          • Jose Luis Diez Gil, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCB-PCI
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.
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.
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Baseline to 3 month follow-up.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of minimum lumen change baseline to 3 month follow-up.
Time Frame: Baseline to 3 month follow-up.
Baseline to 3 month follow-up.
Percentage of plaque burden change baseline to 3 month follow-up.
Time Frame: Baseline to 3 month follow-up.
Baseline to 3 month follow-up.
Rate of IMRangio change from baseline to post DCB-PCI
Time Frame: Baseline to post DCB-PCI
Baseline to post DCB-PCI
Rate of IMRangio change from post DCB-PCI to 3 month follow-up
Time Frame: Post DCB-PCI to 3 month follow-up
Post DCB-PCI to 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data would be shared under appropriate request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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