Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-10 @ 10:55 PM
Study NCT ID:
NCT04181268
Status:
UNKNOWN
Last Update Posted:
2021-03-01
First Post:
2019-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis
Sponsor:
Hospital Universitario La Paz
Organization:
Study Overview
Official Title:
Roller Coaster Trial: Rotational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
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:
ROLLERCOASTR
Brief Summary:
Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.
However there is no direct randomized comparison between these three tools in this scenario.
The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.
However there is no direct randomized comparison between these three tools in this scenario.
The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.
Detailed Description:
Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.
However there is no direct randomized comparison between these three tools in this scenario.
The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.
The primary endpoint will be the percentage of stent expansion measured with optical coherence tomography. Between secondary endpoints we will analyze the strategy success (defined as successful stent delivery and expansion with \<20% residual stenosis and TIMI 3 flow without crossover or stent failure) and presentation of clinical adverse at 1 year follow-up .
However there is no direct randomized comparison between these three tools in this scenario.
The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.
The primary endpoint will be the percentage of stent expansion measured with optical coherence tomography. Between secondary endpoints we will analyze the strategy success (defined as successful stent delivery and expansion with \<20% residual stenosis and TIMI 3 flow without crossover or stent failure) and presentation of clinical adverse at 1 year follow-up .
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: