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Atherectomy vs Intravascular Lithotripsy (RAINBOW)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease | Diagnostic Test: Rotational atherectomy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Parallel assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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 |
| Estimated Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Rotational atherectomy
Patients will undergo rotational atherectomy
|
Diagnostic Test: Rotational atherectomy
Rotational atherectomy
|
|
Experimental: Intravascular lithotripsy
Patients will undergo intravascular lithotripsy
|
Diagnostic Test: Rotational atherectomy
Rotational atherectomy
|
- 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
- Optical coherence tomography (OCT) [ Time Frame: Up to 1 day ]The acute lumen gain as assessed by OCT in the two groups
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
• Patients with acute coronary syndromes
| Contact: Francesco Pelliccia | +390633062615 | f.pelliccia@mclink.it |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 7, 2019 | ||||
| First Posted Date ICMJE | July 10, 2019 | ||||
| Last Update Posted Date | July 12, 2019 | ||||
| Estimated Study Start Date ICMJE | September 1, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE |
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
|
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
Optical coherence tomography (OCT) [ Time Frame: Up to 1 day ] The acute lumen gain as assessed by OCT in the two groups
|
||||
| Original Secondary Outcome Measures ICMJE |
OCT [ Time Frame: Up to 1 day ] The acute lumen gain as assessed by OCT in the two groups
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Atherectomy vs Intravascular Lithotripsy | ||||
| Official Title ICMJE | Randomized Comparison of Rotational Atherectomy vs INtravascular Lithotripsy for Plaque Modification Before Stent implantatiOn in Patients With Severely Calcified Coronary Lesions: The RAINBOW Trial | ||||
| Brief 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 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Parallel assignment Masking: None (Open Label)Primary Purpose: Diagnostic |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Diagnostic Test: Rotational atherectomy
Rotational atherectomy
|
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| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: • Patients with acute coronary syndromes |
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04013906 | ||||
| Other Study ID Numbers ICMJE | 2019/D/389 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | Francesco Pelliccia, University of Roma La Sapienza | ||||
| Study Sponsor ICMJE | University of Roma La Sapienza | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | University of Roma La Sapienza | ||||
| Verification Date | July 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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