Calcified Coronary Artery Disease, Chronic Total Occlusion (CTO), Coronary Artery Disease, In Stent Restenosis
Conditions
Keywords
Percutaneous coronary intervention, excimer laser coronary atherectomy, intravascular imaging, optical coherence tomography, complex coronary intervention
Brief summary
This will be an investigator-initiated, multicentre, single-arm, open-label, prospective observational study. Patients with indication for PCI and undilatable (non-compliant balloon dilatation \<80% at burst pressure) or uncrossable (not crossable with a small-profile balloon with adequate support, according to operator´s discretion) coronary lesions treated with ELCA will be included. Intravascular imaging will be highly recommendable and analysed in a central core-laboratory. Device success, angiographical success, procedural success, clinical success and related complications will be evaluated. Patients will be followed for 1 year after the procedure and clinical events will be recorded.
Interventions
DEVICELaser atherectomy
ELCA procedure will be performed using the Spectranetics CVX300 (Spectranetics, Colorado Spring, CO, USA) and the latest generation Philips Laser System Excimer (Philips, San Diego, CA, USA) System, which is based on pulsed xenon-chlorine laser catheters capable of delivering excimer energy (wavelength 308 nm, pulse length 185 ns) from 30 to 80 mJ/mm2 (fluencies) at pulse repetition rates from 25 to 80 Hz. The ELCA technique will be performed according to current recommendations (18). The laser probe size will be at the operator´s discretion among the available options (rapid exchange concentric 0.9 mm, 1.4 mm, 1.7mm or 2.0mm). The selection of fluence, and repetition rate will be left to the operator. A saline infusion technique will be recommended, although application of laser with blood or contrast will be recommended in resistant lesions. In the event of unsuccessful initial therapy, additional plaque modification techniques may be employed at the discretion of the operator and wi
Sponsors
Hospital Universitario La Paz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged over 18 years. * Patients with either stable coronary artery disease or acute coronary syndromes as the clinical presentation. * Patients with severe coronary lesions (\>70% by visual estimation) in native vessels or coronary bypass grafts. * Uncrossable coronary lesions (i.e., lesions that cannot be crossed with a 0.7:1 balloon after successful guidewire passage) or Undilatable lesions (i.e., those in which balloon dilation with a 1:1 non-compliant balloon at 18 atm results in less than 80% expansion relative to the distal reference vessel diameter; this group includes both de novo lesions and in-stent restenosis or underexpanded stents).
Exclusion criteria
* Patients with known allergies to aspirin (ASA), clopidogrel, prasugrel, or ticagrelor. * Patients unable to provide informed consent, either personally or through a legal representative. * Patients with clinical or hemodynamic instability defined as: sustained hypotension (systolic blood pressure ≤ 90 mmHg for ≥ 30 minutes or use of pharmacological and/or mechanical support to maintain an SBP ≥90 mmHg) or evidence of end-organ hypoperfusion including urine output of \<30 mL/h, cool extremities, altered mental status, and/or serum lactate \>2.0 mmol/L. * Patients with significant comorbidities and a life expectancy of less than one year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laser Success | From enrollment to the end of the procedure at 4 hours. | For uncrossable lesions, it will be defined as the ability of the laser catheter to cross the lesion. Laser success will be also considered in cases in which the laser catheter cannot cross the lesion but its application proximal to it allows subsequent crossing of balloons. For undilatable lesions, laser success will be defined as successful balloon dilation (sized 1:1 to the vessel diameter), with adequate expansion (\>80% in two orthogonal projections) following laser therapy without the need of other plaque modification technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic success | From enrollment to the end of the procedure at 4 hours. | Thrombolysis in myocardial infarction (TIMI) 3 final flow and a diameter stenosis \<20%. |
| Procedural success | From enrollment to the end of the procedure at 4 hours. | Angiographic success without severe procedural complications (death, coronary perforation, abrupt vessel closure, flow-limiting dissection). |
| Intracoronary imaging-based success | From enrollment to the end of the procedure at 4 hours. | Stent expansion ≥80% \[OCT or intravascular ultrasound (IVUS)\] or a minimal stent area (MSA) ≥4.5mm2 in OCT or ≥5.5mm2 in IVUS. |
| Events at 1 year | From enrollment to 1 year after the procedure | Clinical events and antiplatelet therapy will be recorded, including the rate of major cardiovascular events (MACE), defined as the occurrence of cardiac death, target vessel acute myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis), death, cardiovascular death, non-fatal MI, target lesion revascularization (TLR), TVR, stroke and bleeding. |
Countries
Spain
Outcome results
None listed