Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-21 @ 10:11 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2019-11-26', 'lastUpdatePostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of stent expansion by optical coherence tomography', 'timeFrame': 'At the end of percutaneous coronary intervention', '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).'}], 'secondaryOutcomes': [{'measure': 'Strategy success rate', 'timeFrame': 'At the end of percutaneous coronary intervention', 'description': 'Successful stent delivery and expansion with \\<20% residual stenosis and TIMI3 flow without crossover or stent failure.\n\nSuccessful stent delivery and expansion with \\<20% residual stenosis and TIMI3 flow without crossover or stent failure.\n\nSuccessful stent delivery and expansion with residual stenosis \\<20% and TIMI 3 without crossover'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.\n\nHowever there is no direct randomized comparison between these three tools in this scenario.\n\nThe 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.', 'detailedDescription': 'Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.\n\nHowever there is no direct randomized comparison between these three tools in this scenario.\n\nThe 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.\n\nThe 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 .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years.\n* Stenosis ≥70% in a coronary artery with a diameter ≥2,5 y ≤4 mm.\n* Moderate to severe angiographic calcification\n* Stable coronary artery disease or NSTEMI.\n* Native coronary vessel or bypass graft.\n\nExclusion Criteria:\n\n* Knwon allergies to aspirin or P2y12 inhibitors.\n* STEMI.\n* Cardiogenic shock at the time of PCI.\n* Treated lesion in a bifurcation with side branch diameter \\> 2mm.\n* Absence of informed consent.\n* Impossibility for 1year follow up.'}, 'identificationModule': {'nctId': 'NCT04181268', 'acronym': 'ROLLERCOASTR', 'briefTitle': 'ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': 'Roller Coaster Trial: Rotational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified', 'orgStudyIdInfo': {'id': '0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rotational Atherectomy', '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.\n\nThe 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.\n\nThe 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.\n\nAfter 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.', 'interventionNames': ['Device: Percutaneous coronary Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravascular Lithotripsy', '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.\n\nThe 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.\n\nAlter IVL, an optional additional post-dilatation with non-compliant balloons, a stent is implanted', 'interventionNames': ['Device: Percutaneous coronary Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Excimer Laser', '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.\n\nExcimer 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', 'interventionNames': ['Device: Percutaneous coronary Intervention']}], 'interventions': [{'name': 'Percutaneous coronary Intervention', 'type': 'DEVICE', 'description': 'Calcified plaque modification during percutaneous coronary intervention', 'armGroupLabels': ['Excimer Laser', 'Intravascular Lithotripsy', 'Rotational Atherectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alfonso Jurado', 'role': 'CONTACT', 'email': 'alfonsojuradoroman@gmail.com', 'phone': '0034629871863'}], 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alfonso Jurado, MD, PhD', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}