Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Calcification
  • Coronary (Artery) Disease
  • Intracoronary Lithotripsy
  • Optical Coherence Tomography
  • Percutaneous Coronary Intervention
  • Stent
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Calcified coronary artery disease continues to present a challenge for Interventional Cardiologists. Moderate calcification is found in over 25% of coronary artery lesions planned for percutaneous coronary intervention (PCI). Outcomes for patients undergoing PCI to calcified lesions have been shown ...

Calcified coronary artery disease continues to present a challenge for Interventional Cardiologists. Moderate calcification is found in over 25% of coronary artery lesions planned for percutaneous coronary intervention (PCI). Outcomes for patients undergoing PCI to calcified lesions have been shown to be consistently poorer than in non-calcified lesions. Recently, intravascular lithotripsy has become available for the treatment of calcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored. This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain. Patients with an indication of PCI and with a significant calcium burden requiring modification will be invited to participate. PCI procedures will be performed via either radial or femoral access as deemed appropriate by the operator and in accordance with local protocols. Intravascular imaging using OCT will be performed prior to calcium modification to define the pattern of calcium, after calcium modification to assess the effectiveness of IVL therapy and after stent implantation to assess stent expansion.

Tracking Information

NCT #
NCT04698902
Collaborators
Not Provided
Investigators
Not Provided