Coronary Artery DiseaseNCT04698902
Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy
An observational study of Coronary Artery Disease and Intracoronary Lithotripsy, run by Fundacion Investigacion Interhospitalaria Cardiovascular at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Intracoronary Lithotripsy, Optical Coherence Tomography
- What is being tested?
- Intracoronary lithotripsy
- Type of treatment
- Medical device
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 1 May 2022
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients with calcified coronary artery disease planned for percutaneous coronary intervention and stenting with the use of intravascular lithotripsy for calcium modification prior to stenting.
Who may be able to join
- Patients >18 years of age
- Patients with an indication for PCI (ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of >50% de novo severely calcified coronary stenosis that requires IVL treatment.
Who cannot join
- Patients unwilling or unable to sign informed consent for the procedure
- Patients with severe peripheral vascular disease limiting vascular access to the extent that it is unsafe to perform the procedure
- Patients with severe renal dysfunction (eGFR <15mls/min and not receiving dialysis)
- Treatment of vessels < 2.5mm diameter which are not amenable to IVL treatment or OCT assessment.
- Treatment of lesions located very distally in the coronary vessel where the OCT catheter may not reach.
- Inability to cross the lesion with the OCT catheter due to very severe stenosis or severe vessel tortuosity.
- Ostial left main stem or right coronary artery lesions which may be difficult to visualise by OCT
- Patients requiring concomitant use of rotational or orbital atherectomy of LASER.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- Intracoronary lithotripsy
- Medical subject headings
- Coronary Artery Disease, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary lithotripsyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Circumferential calcification | Patients with circumferential pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium >180 degrees) Receives: Device: Intracoronary lithotripsy | |
| Eccentric calcification | Patients with an eccentric pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium <180 degrees) Receives: Device: Intracoronary lithotripsy | |
| Nodular calcification | Patients with calcium nodules identified by OCT (Optical coherence tomography) assessment Receives: Device: Intracoronary lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of lesions with Calcium Fractures
Percentage of lesions showing calcium modification (fractures) after intravascular lithotripsy (IVL) in nodular eccentric and concentric calcium patterns
Measured: At the time of percutaneous coronary intervention
Secondary outcomes (6)
Number of calcium fractures
Number of calcium fractures visible on OCT after IVL treatment
Measured: At the time of percutaneous coronary intervention
Number of quadrants with calcium fractures
Number of quadrants with calcium fractures after IVL treatment as assessed by OCT
Measured: At the time of percutaneous coronary intervention
Calcium modification in eccentric versus concentric calcium
Percentage of lesions with calcium arc <180 versus >180 degrees with fractures as assessed by OCT
Measured: At the time of percutaneous coronary intervention
Stent expansion
Percentage stent expansion in patients with and without calcium modification (fractures) after application of IVL
Measured: At the time of percutaneous coronary intervention
Stent symmetry
Stent symmetry index in patients with and without calcium modification (fractures) after IVL application
Measured: At the time of percutaneous coronary intervention
Stent symmetry
Stent symmetry index in patients with concentric versus eccentric calcification
Measured: At the time of percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Nov 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nieves Gonzalo, Fundacion Investigacion Interhospitalaria Cardiovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698902
- Sponsor's protocol ID
- 20/599-E
- Status last verified
- Mar 2024
- First submitted
- 5 Jan 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy
- ClinicalTrials.gov ID
- NCT04698902
- Acronym / sponsor ID
- 20/599-E
- Conditions
- Coronary Artery Disease, Intracoronary Lithotripsy, Optical Coherence Tomography, Percutaneous Coronary Intervention, Calcification, Stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Fundacion Investigacion Interhospitalaria CardiovascularUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 7 Jan 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circumferential calcification | – | Device: Intracoronary lithotripsyPatients with circumferential pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium >180 degrees) |
| Eccentric calcification | – | Device: Intracoronary lithotripsyPatients with an eccentric pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium <180 degrees) |
| Nodular calcification | – | Device: Intracoronary lithotripsyPatients with calcium nodules identified by OCT (Optical coherence tomography) assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with calcified coronary artery disease planned for percutaneous coronary intervention and stenting with the use of intravascular lithotripsy for calcium modification prior to stenting.
Key inclusion criteria (2 listed)
- Patients >18 years of age
- Patients with an indication for PCI (ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of >50% de novo severely calcified coronary stenosis that requires IVL treatment.
Key exclusion criteria (8 listed)
- Patients unwilling or unable to sign informed consent for the procedure
- Patients with severe peripheral vascular disease limiting vascular access to the extent that it is unsafe to perform the procedure
- Patients with severe renal dysfunction (eGFR <15mls/min and not receiving dialysis)
- Treatment of vessels < 2.5mm diameter which are not amenable to IVL treatment or OCT assessment.
- Treatment of lesions located very distally in the coronary vessel where the OCT catheter may not reach.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracoronary lithotripsyIntracoronary 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. | Device | Circumferential calcification, Eccentric calcification, Nodular calcification |
Primary outcome
Percentage of lesions with Calcium Fractures
Time frame: At the time of percutaneous coronary intervention
Percentage of lesions showing calcium modification (fractures) after intravascular lithotripsy (IVL) in nodular eccentric and concentric calcium patterns
6 secondary outcomes
Number of calcium fractures
Time frame: At the time of percutaneous coronary intervention
Number of quadrants with calcium fractures
Time frame: At the time of percutaneous coronary intervention
Calcium modification in eccentric versus concentric calcium
Time frame: At the time of percutaneous coronary intervention
Stent expansion
Time frame: At the time of percutaneous coronary intervention
Stent symmetry
Time frame: At the time of percutaneous coronary intervention
Stent symmetry
Time frame: At the time of percutaneous coronary intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Intracoronary Lithotripsy, run by Fundacion Investigacion Interhospitalaria Cardiovascular at 1 site in Spain.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of lesions with Calcium Fractures (time frame: At the time of percutaneous coronary intervention). 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 6 Mar 2024.