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ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis (ROLLERCOASTR)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous coronary Intervention
Sponsored by
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients >18 years.
  • Stenosis ≥70% in a coronary artery with a diameter ≥2,5 y ≤4 mm.
  • Moderate to severe angiographic calcification
  • Stable coronary artery disease or NSTEMI.
  • Native coronary vessel or bypass graft.

Exclusion Criteria:

  • Knwon allergies to aspirin or P2y12 inhibitors.
  • STEMI.
  • Cardiogenic shock at the time of PCI.
  • Treated lesion in a bifurcation with side branch diameter > 2mm.
  • Absence of informed consent.
  • Impossibility for 1year follow up.

Sites / Locations

  • La Paz University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Rotational Atherectomy

Intravascular Lithotripsy

Excimer Laser

Arm Description

The procedure is performed by using a Rotablator system, which consists of a spring coil shaft with a burr at the tip. The front edge of the burr is the ablating portion, oval shaped, and covered with fine diamond crystals. The rotational atherectomy catheter is introduced into the coronary artery over a dedicated long rotational atherectomy wire, which consists of a monofilament stainless steel 0.09-inch wire. The device is connected to a console that houses the turbine that rotates the burr with pressurized nitrogen gas. Typically the rpm is set at 150,000 to 180,000 rpm. After the lesion is crossed with the wire, the lesion is crossed with multiple "pecking" movements of the burr, with each run lasting not more than 20 seconds. After successful rotational atherectomy with one or more burrs, the procedure is completed with balloon angioplasty and stent placement. This can be achieved by exchanging the rota wire with a workhorse wire and using standard equipment.

The procedure is perforemed with a Coronary intravascular lithotripsy (IVL) System that consists of a generator, a connector cable with a push button to allow manually controlled delivery of electric pulses, and semi-compliant balloon catheter. The balloon integrates two radiopaque lithotripsy emitters 6 mm that receive electrical pulses from the generator vaporising the fluid within the balloon and creating a rapidly expanding and collapsing bubble. This bubble can transmit unfocused circumferential pulsatile mechanical energy into the vessel wall, in the form of sonic pressure waves equivalent to approximately 50 atmospheres (atm). The IVL therapy consists on a maximun of 8 runs of 10 pulses (80 pulses). The number of therapies needed per lesion will depend on lesion resistance; however, a mínimum of 20 pulses is recommended. Alter IVL, an optional additional post-dilatation with non-compliant balloons, a stent is implanted

Excimer laser is pulsed gas laser that use Xenon chloride (XeCl) as the active medium to generate pulses of short wavelength, high-energy ultraviolet (UV) light. Excimer laser tissue ablation is mediated through three distinct mechanisms: photochemical, photo-thermal and photomechanical. UV laser light is absorbed by intra-vascular material and breaks carbon-carbon bonds (photochemical). It elevates the temperature of intra-cellular water, causing cellular rupture and generates a vapor bubble at the catheter tip (photo-thermal). Expansion and implosion of these bubbles disrupts the obstructive intra-vascular material (photomechanical). The laser catheter is advanced slowly over a conventional wire while the therapy is aplied and saline is inffused. After laser, balloon dilatation is usually performed finishing the procedure with stent implantation

Outcomes

Primary Outcome Measures

Percentage of stent expansion by optical coherence tomography
We will analyze with optical coherence tomography the percentage of stent expansion (defined as the minimal stent area divided by the mean of the proximal and distal reference lumen areas).

Secondary Outcome Measures

Strategy success rate
Successful stent delivery and expansion with <20% residual stenosis and TIMI3 flow without crossover or stent failure. Successful stent delivery and expansion with <20% residual stenosis and TIMI3 flow without crossover or stent failure. Successful stent delivery and expansion with residual stenosis <20% and TIMI 3 without crossover

Full Information

First Posted
November 20, 2019
Last Updated
February 25, 2021
Sponsor
Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT04181268
Brief Title
ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis
Acronym
ROLLERCOASTR
Official Title
Roller Coaster Trial: Rotational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rotational Atherectomy
Arm Type
Active Comparator
Arm Description
The procedure is performed by using a Rotablator system, which consists of a spring coil shaft with a burr at the tip. The front edge of the burr is the ablating portion, oval shaped, and covered with fine diamond crystals. The rotational atherectomy catheter is introduced into the coronary artery over a dedicated long rotational atherectomy wire, which consists of a monofilament stainless steel 0.09-inch wire. The device is connected to a console that houses the turbine that rotates the burr with pressurized nitrogen gas. Typically the rpm is set at 150,000 to 180,000 rpm. After the lesion is crossed with the wire, the lesion is crossed with multiple "pecking" movements of the burr, with each run lasting not more than 20 seconds. After successful rotational atherectomy with one or more burrs, the procedure is completed with balloon angioplasty and stent placement. This can be achieved by exchanging the rota wire with a workhorse wire and using standard equipment.
Arm Title
Intravascular Lithotripsy
Arm Type
Active Comparator
Arm Description
The procedure is perforemed with a Coronary intravascular lithotripsy (IVL) System that consists of a generator, a connector cable with a push button to allow manually controlled delivery of electric pulses, and semi-compliant balloon catheter. The balloon integrates two radiopaque lithotripsy emitters 6 mm that receive electrical pulses from the generator vaporising the fluid within the balloon and creating a rapidly expanding and collapsing bubble. This bubble can transmit unfocused circumferential pulsatile mechanical energy into the vessel wall, in the form of sonic pressure waves equivalent to approximately 50 atmospheres (atm). The IVL therapy consists on a maximun of 8 runs of 10 pulses (80 pulses). The number of therapies needed per lesion will depend on lesion resistance; however, a mínimum of 20 pulses is recommended. Alter IVL, an optional additional post-dilatation with non-compliant balloons, a stent is implanted
Arm Title
Excimer Laser
Arm Type
Active Comparator
Arm Description
Excimer laser is pulsed gas laser that use Xenon chloride (XeCl) as the active medium to generate pulses of short wavelength, high-energy ultraviolet (UV) light. Excimer laser tissue ablation is mediated through three distinct mechanisms: photochemical, photo-thermal and photomechanical. UV laser light is absorbed by intra-vascular material and breaks carbon-carbon bonds (photochemical). It elevates the temperature of intra-cellular water, causing cellular rupture and generates a vapor bubble at the catheter tip (photo-thermal). Expansion and implosion of these bubbles disrupts the obstructive intra-vascular material (photomechanical). The laser catheter is advanced slowly over a conventional wire while the therapy is aplied and saline is inffused. After laser, balloon dilatation is usually performed finishing the procedure with stent implantation
Intervention Type
Device
Intervention Name(s)
Percutaneous coronary Intervention
Intervention Description
Calcified plaque modification during percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Percentage of stent expansion by optical coherence tomography
Description
We will analyze with optical coherence tomography the percentage of stent expansion (defined as the minimal stent area divided by the mean of the proximal and distal reference lumen areas).
Time Frame
At the end of percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
Strategy success rate
Description
Successful stent delivery and expansion with <20% residual stenosis and TIMI3 flow without crossover or stent failure. Successful stent delivery and expansion with <20% residual stenosis and TIMI3 flow without crossover or stent failure. Successful stent delivery and expansion with residual stenosis <20% and TIMI 3 without crossover
Time Frame
At the end of percutaneous coronary intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >18 years. Stenosis ≥70% in a coronary artery with a diameter ≥2,5 y ≤4 mm. Moderate to severe angiographic calcification Stable coronary artery disease or NSTEMI. Native coronary vessel or bypass graft. Exclusion Criteria: Knwon allergies to aspirin or P2y12 inhibitors. STEMI. Cardiogenic shock at the time of PCI. Treated lesion in a bifurcation with side branch diameter > 2mm. Absence of informed consent. Impossibility for 1year follow up.
Facility Information:
Facility Name
La Paz University Hospital
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Jurado
Phone
0034629871863
Email
alfonsojuradoroman@gmail.com

12. IPD Sharing Statement

Learn more about this trial

ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis

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