Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 4:26 AM
Study NCT ID:
NCT04013906
Status:
UNKNOWN
Last Update Posted:
2019-07-12
First Post:
2019-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atherectomy vs Intravascular Lithotripsy
Sponsor:
University of Roma La Sapienza
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAINBOW
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: