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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| undilatable lesions | expansion <80% of the distal vessel diameter after inflation of a 1:1 non-compliant balloon at 18 atm |
| |
| uncrossable coronary lesions | (not crossable after using a small-profile balloon with adequate support, according to operator´s discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser atherectomy | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Laser Success | 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. | From enrollment to the end of the procedure at 4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic success | Thrombolysis in myocardial infarction (TIMI) 3 final flow and a diameter stenosis <20%. | From enrollment to the end of the procedure at 4 hours. |
| Procedural success | Angiographic success without severe procedural complications (death, coronary perforation, abrupt vessel closure, flow-limiting dissection). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indication for PCI and undilatable or uncrossable lesions treated with ELCA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Madrid | Spain |
Individual participant data (IPD) will not be publicly shared; however, data sharing may be considered in selected cases upon reasonable request and with sufficient justification.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| From enrollment to the end of the procedure at 4 hours. |
| Intracoronary imaging-based success | Stent expansion ≥80% [OCT or intravascular ultrasound (IVUS)] or a minimal stent area (MSA) ≥4.5mm2 in OCT or ≥5.5mm2 in IVUS. | From enrollment to the end of the procedure at 4 hours. |
| Events at 1 year | 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. | From enrollment to 1 year after the procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |