Trials / Completed
CompletedNCT04698902
Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 96 (actual)
- Sponsor
- Fundacion Investigacion Interhospitalaria Cardiovascular · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
Calcified coronary artery disease is a frequently encountered problem that can lead to poorer outcomes for patients undergoing PCI. Recently, intravascular lithotripsy has become available for the treatment of callcified 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 examining the effect of intravasuclar lithotripsy in varying calcium patterns. 100 patients wll be enrolled. Optical coherence tomography will be used to assess the effect of intravascular lithotripsy on varying calcium patterns (concentric, eccentric and nodular).
Detailed 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 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.
Conditions
- Coronary Artery Disease
- Intracoronary Lithotripsy
- Optical Coherence Tomography
- Percutaneous Coronary Intervention
- Calcification
- Stent
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intracoronary lithotripsy | Intracoronary lithotripsy involves the use of sonic pressure waves generated from emitters enclosed within a balloon delivery system. The generated sonic waves act to fracture calcium within the coronary artery wall. |
Timeline
- Start date
- 2020-11-01
- Primary completion
- 2022-05-01
- Completion
- 2022-05-01
- First posted
- 2021-01-07
- Last updated
- 2024-03-06
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04698902. Inclusion in this directory is not an endorsement.