Coronary Artery DiseaseRAINBOWNCT04013906
Atherectomy vs Intravascular Lithotripsy
A study testing Rotational atherectomy in people with Coronary Artery Disease, run by University of Roma La Sapienza.
Trial summary
Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI. However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no randomized comparisons between rotational atherectomy and intravascular lithotripsy have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rotational atherectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 31 Dec 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reference vessel diameter of 2.5-4.0 mm and lesion lengths of 40 mm or less involving a de novo coronary stenosis.
- Vessel calcification must be severe angiographically as evidenced by calcium present on both sides of the vessel and extending ≥15 mm or by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) with presence of a calcium arc ≥270° in at least one cross-section.
- Calcifications should not be unable to cross with a balloon
Who cannot join
- Patients with acute coronary syndromes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Comparison of Rotational Atherectomy vs INtravascular Lithotripsy for Plaque Modification Before Stent implantatiOn in Patients With Severely Calcified Coronary Lesions: The RAINBOW Trial
Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI.
However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no randomized comparisons between rotational atherectomy and intravascular lithotripsy have been carried out so far.
The aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive plaque modification with rotational atherectomy vs. intravascular lithotripsy before placement of a drug-eluting stent.
Read the detailed description
Calcification of the coronary lesion is challenging during percutaneous coronary intervention (PCI) since it can cause the balloon dilation to fail with subsequent incomplete and asymmetrical stent expansion. Also, calcified coronary lesions are associated with increased risk of adverse events after PCI, such as stent restenosis and thrombosis.
Several devices and techniques have been proposed to treat severely calcified coronary lesions. For many years, modification of these lesions with rotational atherectomy has been considered the gold standard to ease the process of angioplasty and PCI. Recently, intravascular lithotripsy (IVL) has been proposed as an alternative to rotational atherectomy for the treatment of calcified de-novo coronary lesions. The Shockwave Medical Coronary Rx Intravascular Lithotripsy (IVL) System (Shockwave Medical Inc., Fremont, California, USA) is a novel balloon catheter-based device able to disrupt calcified lesions using technology like lithotripsy for kidney stones. Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI.
However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no randomized comparisons between rotational atherectomy and intravascular lithotripsy have been carried out so far.
The aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive plaque modification with rotational atherectomy vs. intravascular lithotripsy before placement of a drug-eluting stent.
- Conditions
- Coronary Artery Disease
- Being tested
- Rotational atherectomy
- Keywords
- coronary artery disease, calcium, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational atherectomyDiagnostic test
Rotational atherectomy
| Study group | Role | What they receive |
|---|---|---|
| Rotational atherectomy | Experimental | Patients will undergo rotational atherectomy Receives: Diagnostic Test: Rotational atherectomy |
| Intravascular lithotripsy | Experimental | Patients will undergo intravascular lithotripsy Receives: Diagnostic Test: Rotational atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
The time to first occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization
Measured: Up to 30 days
Secondary outcomes (1)
Optical coherence tomography (OCT)
The acute lumen gain as assessed by OCT in the two groups
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013906
- Sponsor's protocol ID
- 2019/D/389
- Acronym
- RAINBOW
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 12 Jul 2019
- 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 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Rotational Atherectomy vs INtravascular Lithotripsy for Plaque Modification Before Stent implantatiOn in Patients With Severely Calcified Coronary Lesions: The RAINBOW Trial
- ClinicalTrials.gov ID
- NCT04013906
- Acronym / sponsor ID
- RAINBOW / 2019/D/389
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, calcium, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Jul 2019 (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.
Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI.
However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no randomized comparisons between rotational atherectomy and intravascular lithotripsy have been carried out so far.
The aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive plaque modification with rotational atherectomy vs. intravascular lithotripsy before placement of a drug-eluting stent.
Detailed description
Calcification of the coronary lesion is challenging during percutaneous coronary intervention (PCI) since it can cause the balloon dilation to fail with subsequent incomplete and asymmetrical stent expansion. Also, calcified coronary lesions are associated with increased risk of adverse events after PCI, such as stent restenosis and thrombosis.
Several devices and techniques have been proposed to treat severely calcified coronary lesions. For many years, modification of these lesions with rotational atherectomy has been considered the gold standard to ease the process of angioplasty and PCI. Recently, intravascular lithotripsy (IVL) has been proposed as an alternative to rotational atherectomy for the treatment of calcified de-novo coronary lesions. The Shockwave Medical Coronary Rx Intravascular Lithotripsy (IVL) System (Shockwave Medical Inc., Fremont, California, USA) is a novel balloon catheter-based device able to disrupt calcified lesions using technology like lithotripsy for kidney stones. Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI.
However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no randomized comparisons between rotational atherectomy and intravascular lithotripsy have been carried out so far.
The aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive plaque modification with rotational atherectomy vs. intravascular lithotripsy before placement of a drug-eluting stent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Rotational atherectomy | Experimental | Diagnostic Test: Rotational atherectomyPatients will undergo rotational atherectomy |
| Intravascular lithotripsy | Experimental | Diagnostic Test: Rotational atherectomyPatients will undergo intravascular lithotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Reference vessel diameter of 2.5-4.0 mm and lesion lengths of 40 mm or less involving a de novo coronary stenosis.
- Vessel calcification must be severe angiographically as evidenced by calcium present on both sides of the vessel and extending ≥15 mm or by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) with presence of a calcium arc ≥270° in at least one cross-section.
- Calcifications should not be unable to cross with a balloon
Key exclusion criteria (1 listed)
- Patients with acute coronary syndromes
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 |
|---|---|---|
| Rotational atherectomyRotational atherectomy | Diagnostic test | Intravascular lithotripsy, Rotational atherectomy |
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: Up to 30 days
The time to first occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization
1 secondary outcome
Optical coherence tomography (OCT)
Time frame: Up to 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Rotational atherectomy in people with Coronary Artery Disease, run by University of Roma La Sapienza.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pelliccia (+390633062615, f.pelliccia@mclink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: Up to 30 days). 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 12 Jul 2019.