Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions
NCT05016726 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400
Last updated 2021-08-23
Summary
To evaluate intra-procedural and long-term effects of intravascular lithotripsy with the ShockWave System and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined group of patients with complex calcified coronary artery lesions.
Conditions
Interventions
- DEVICE
-
Intravascular Lithotripsy
Intravascular Lithotripsy and/or Rotational Atherectomy and/or Orbital Atherectomy to the target vessel prior to placing a coronary stent.
Sponsors & Collaborators
-
SS Annunziata Hospital, Savigliano
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-01
- Primary Completion
- 2023-10-01
- Completion
- 2024-10-30
- FDA Device
- Yes
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