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Drug-eluting stent (DES) implantation as interventional strategy for lesions in small coronary arteries is the current standard of care in many centers worldwide, but is associated with increased risk of late treatment failure in small vessels, as compared with larger coronary arteries. Randomized and observational studies have been shown that coronary intervention with drug-coated balloons (DCB) provide a promising alternative to DES implantation in small vessels, while avoiding the risk of a permanent vascular implant. Furthermore, lesions in small vessels are frequently concomitant with diffuse disease and/or distal location, where the presence of calcification is an additional common feature. Intravascular lithotripsy (IVL) has been recently introduced as a novel adjunctive technology to treat calcified lesions.
This study will explore the hypothesis that IVL has the potential to enhance the results of coronary balloon dilatation of small vessels with calcified lesions, therefore increasing the likelihood of optimal DBC intervention.
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| Measure | Description | Time Frame |
|---|---|---|
| Successful IVL plus DCB | Successful IVL plus DCB in the absence of target lesion failure (TLF); "Successful IVL plus DCB" will be defined as a composite of:
TLF will be defined as a composite of clinically driven revascularization, OR myocardial infarction, OR cardiac death related to the target lesion. | at 1 month follow-up |
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Inclusion Criteria:
Age 18 years or older
Coronary artery disease with percutaneous intervention clinically indicated to treat one or more lesions fulfilling all criteria below:
Written informed consent
Exclusion Criteria:
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Patients with a diminished blood flow in their calcified small coronary vessels
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annelena Held-Wehmöller, PhD | Contact | +4915785128140 | shockwave_dcb@redeoptimus.com |
| Name | Affiliation | Role |
|---|---|---|
| Flavio Ribichini, MD | Universita di Verona | Principal Investigator |
| Pedro Lemos, MD | Hospital Israelita Albert Einstein, São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | Recruiting | São Paulo | Brazil |
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| University of Verona | Recruiting | Verona | Italy |
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