Clinical trial NCT05625997: Shockwave IVL + DCB
Official title: Intravascular Lithotripsy Plus Drug-coated Balloon in Calcified Small Coronary Vessels: a Feasibility Exploratory Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Calcified Lesions in Small Coronary Vessels
Lead sponsor: Rede Optimus Hospitalar SA
Sponsor class: NETWORK
First posted: 2022-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diminished blood flow in their calcified small coronary vessels

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Coronary artery disease with percutaneous intervention clinically indicated to treat one or more lesions fulfilling all criteria below:

   * De novo lesion with diameter stenosis \> 50% (visual analysis)
   * Coronary vessel diameter \< 3.0 mm (visual analysis)
   * Severe calcification at the target segment, defined as fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least 1 location OR Intravascular Ultrasound/Optical Coherence Tomography (IVUS/OCT) demonstrated calcium angle of ≥270° on at least 1 cross section.
3. Written informed consent

Exclusion Criteria:

1. Previous coronary intervention at or \< 10 mm distant from target segment at any time.
2. Lesion length ≥ 40 mm.
3. Planned atherectomy or cutting/scoring balloon use.
4. Bifurcation lesion.
5. Thrombus containing lesion.
6. Life expectancy \< 12 months due to other co-morbid condition(s) that could limit patient's ability to participate in clinical study

Primary outcomes:
measure: Successful IVL plus DCB
timeFrame: at 1 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Verona
country: Italy
facility: University of Verona
Study officials:
affiliation: Universita di Verona
name: Flavio Ribichini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Einstein, São Paulo
name: Pedro Lemos, MD
role: PRINCIPAL_INVESTIGATOR
References: