Coronary Artery DiseaseROLLERCOASTRNCT04181268
ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis
A study testing Percutaneous coronary Intervention in people with Coronary Artery Disease, run by Hospital Universitario La Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2020to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
La Paz University Hospital
Madrid, 28046
Alfonso Jurado, 0034629871863, alfonsojuradoroman@gmail.com
About this study
Official title: Roller Coaster Trial: Rotational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified
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.
Read the 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 .
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary InterventionDevice
Calcified plaque modification during percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Rotational Atherectomy | Active comparator | 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. Receives: Device: Percutaneous coronary Intervention |
| Intravascular Lithotripsy | Active comparator | 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 Receives: Device: Percutaneous coronary Intervention |
| Excimer Laser | Active comparator | 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 Receives: Device: Percutaneous coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the end of percutaneous coronary intervention
Secondary outcomes (1)
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
Measured: At the end of percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start15 Nov 2020
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Jurado, MD, PhD, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181268
- Sponsor's protocol ID
- 0001
- Acronym
- ROLLERCOASTR
- Status last verified
- Feb 2021
- First submitted
- 20 Nov 2019
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roller Coaster Trial: Rotational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified
- ClinicalTrials.gov ID
- NCT04181268
- Acronym / sponsor ID
- ROLLERCOASTR / 0001
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rotational Atherectomy | Active comparator | Device: Percutaneous coronary InterventionThe 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. |
| Intravascular Lithotripsy | Active comparator | Device: Percutaneous coronary InterventionThe 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 | Active comparator | Device: Percutaneous coronary InterventionExcimer 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary InterventionCalcified plaque modification during percutaneous coronary intervention | Device | Excimer Laser, Intravascular Lithotripsy, Rotational Atherectomy |
Primary outcome
Percentage of stent expansion by optical coherence tomography
Time frame: At the end of percutaneous coronary intervention
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).
1 secondary outcome
Strategy success rate
Time frame: At the end of percutaneous coronary intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary Intervention in people with Coronary Artery Disease, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of stent expansion by optical coherence tomography (time frame: At the end of percutaneous coronary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.