Atherectomy vs Intravascular Lithotripsy
RAINBOW
Randomized Comparison of Rotational Atherectomy vs INtravascular Lithotripsy for Plaque Modification Before Stent implantatiOn in Patients With Severely Calcified Coronary Lesions: The RAINBOW Trial
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Sep 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 12, 2019
July 1, 2019
2.3 years
July 7, 2019
July 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major adverse cardiovascular events (MACE)
The time to first occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization
Up to 30 days
Secondary Outcomes (1)
Optical coherence tomography (OCT)
Up to 1 day
Study Arms (2)
Rotational atherectomy
EXPERIMENTALPatients will undergo rotational atherectomy
Intravascular lithotripsy
EXPERIMENTALPatients will undergo intravascular lithotripsy
Interventions
Rotational atherectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with acute coronary syndromes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 7, 2019
First Posted
July 10, 2019
Study Start
September 1, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
July 12, 2019
Record last verified: 2019-07