Calcified Lesions in Small Coronary VesselsNCT05625997
Shockwave IVL + DCB
An observational study of Calcified Lesions in Small Coronary Vessels, run by Rede Optimus Hospitalar SA at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcified Lesions in Small Coronary Vessels
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jun 2023to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diminished blood flow in their calcified small coronary vessels
Who may be able to join
- Age 18 years or older
- 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.
- Written informed consent
Who cannot join
- Previous coronary intervention at or < 10 mm distant from target segment at any time.
- Lesion length ≥ 40 mm.
- Planned atherectomy or cutting/scoring balloon use.
- Bifurcation lesion.
- Thrombus containing lesion.
- Life expectancy < 12 months due to other co-morbid condition(s) that could limit patient's ability to participate in clinical study
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Brazil1 site, 1 recruiting
- Recruiting
Hospital Israelita Albert Einstein
São Paulo
Pedro Lemos, MD
Italy1 site, 1 recruiting
- Recruiting
University of Verona
Verona
Flavio Ribichini, MD
About this study
Official title: Intravascular Lithotripsy Plus Drug-coated Balloon in Calcified Small Coronary Vessels: a Feasibility Exploratory Study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- IVL application at the target site, AND
- DCB inflation at the target site, AND
- Residual in-segment diameter stenosis <40% by quantitative coronary angiography, in the absence of final serious angiographic complications (≥ Grade D dissection, perforation, abrupt closure, final TIMI flow ≤ II), AND
- Without the need for bailout scoring/cutting balloon or atherectomy-based strategy, AND
- Without the need for bailout stenting.
TLF will be defined as a composite of clinically driven revascularization, OR myocardial infarction, OR cardiac death related to the target lesion.
Measured: at 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start16 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcified Lesions in Small Coronary VesselsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rede Optimus Hospitalar SA
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Flavio Ribichini, MD, Principal investigator, Universita di VeronaPedro Lemos, MD, Principal investigator, Hospital Israelita Albert Einstein, São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625997
- Sponsor's protocol ID
- RO-220203
- Status last verified
- May 2025
- First submitted
- 15 Nov 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Lithotripsy Plus Drug-coated Balloon in Calcified Small Coronary Vessels: a Feasibility Exploratory Study
- ClinicalTrials.gov ID
- NCT05625997
- Acronym / sponsor ID
- RO-220203
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rede Optimus Hospitalar SAResearch network
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diminished blood flow in their calcified small coronary vessels
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Previous coronary intervention at or < 10 mm distant from target segment at any time.
- Lesion length ≥ 40 mm.
- Planned atherectomy or cutting/scoring balloon use.
- Bifurcation lesion.
- Thrombus containing lesion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful IVL plus DCB
Time frame: at 1 month follow-up
Successful IVL plus DCB in the absence of target lesion failure (TLF); "Successful IVL plus DCB" will be defined as a composite of: * IVL application at the target site, AND * DCB inflation at the target site, AND * Residual in-segment diameter stenosis <40% by quantitative coronary angiography, in the absence of final serious angiographic complications (≥ Grade D dissection, perforation, abrupt closure, final TIMI flow ≤ II), AND * Without the need for bailout scoring/cutting balloon or atherectomy-based strategy, AND * Without the need for bailout stenting. TLF will be defined as a composite of clinically driven revascularization, OR myocardial infarction, OR cardiac death related to the target lesion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Related trials for Calcified Lesions in Small Coronary Vessels
RecruitingObservational study
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
Coronary Artery Disease (CAD), Stenosis Coronary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Flavio Ribichini, MD principal investigator
Universita di Verona
Pedro Lemos, MD principal investigator
Hospital Israelita Albert Einstein, São Paulo
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calcified Lesions in Small Coronary Vessels, run by Rede Optimus Hospitalar SA at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annelena Held-Wehmöller, PhD (+4915785128140, shockwave_dcb@redeoptimus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful IVL plus DCB (time frame: at 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.