NCT04428177

Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

Intravascular Lithotripsy in the Treatment of Calcified Coronary Lesions - Coronary Calcification Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.

Detailed description

The study will include a total of 40 patients with calcified coronary lesions who will be randomised 1:1 to the treatment with IVL (Shockwave; Shockwave Medical, Inc, Santa Clara, USA) or the standard therapy (non-compliat high-pressure or Scoreflex predilatation, rotational atherectomy, etc). Appropriate preparation of the lesions will be followed by DES implantation.

Conditions

• Coronary Artery Calcification

Interventions

Type	Name	Description
DEVICE	Intravascular lithotripsy	Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
DEVICE	Standart therapy	conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-06-11
• Last updated: 2023-09-11

Locations

1 site across 1 country: Czechia