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Studies

Interventional Recruiting

NCT06080919 on ClinicalTrials.gov

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

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

  • Sponsor: Hospital Universitari i Politècnic La Fe
  • Enrollment: 30 (Estimated)
  • Study start: 2022-09-12 (Actual)
  • Primary completion: 2024-02-01 (Estimated)
  • Study completion: 2024-05-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: The study will be an investigator-initiated, single-arm, open-label, pilot study.
  • Masking: None
  • PrimaryPurpose: Treatment

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.

Conditions

  • Coronary Artery Disease
  • Drug Coated-balloon
  • Intravascular Ultrasound
  • Plaque Modification
  • Percutaneous Coronary Intervention
  • Microvascular Coronary Artery Disease

Intervention / Treatment

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

Primary Outcome Measures

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

Countries

Spain

Locations and Investigators

  • Hospital Universitario y Politécnico La Fe, Valencia, Spain (Recruiting)
    • Jorge Sanz Sanchez, MD, PhD
    • Jose Luis Diez Gil, MD, PhD