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

NCT04181268 | Unknown FDA Device

• 1 other identifier: 0001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  At the end of percutaneous coronary intervention

Secondary Outcomes (1)

• Strategy success rate

  At the end of percutaneous coronary intervention

Study Arms (3)

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.

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

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

Device: Percutaneous coronary Intervention

Interventions

Percutaneous coronary Intervention DEVICE

Calcified plaque modification during percutaneous coronary intervention

Excimer Laser; Intravascular Lithotripsy; Rotational Atherectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

La Paz University Hospital

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 29, 2019
• Study Start: November 15, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

ES (1)