N/A
N=28
Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03284229 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion — 25; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Excimer Laser Coronary Atherectomy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spectranetics Corporation
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion |
25; 0 | — |
| PRIMARY Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure |
25; 0 | — |
| PRIMARY Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY TIMI Flow |
0; 12; 9; 4; 0; 0 | — |
| SECONDARY Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity |
14; 8; 3 | — |
| SECONDARY Lesion Morphology - Eccentricity of Coronary Lesion |
17; 8 | — |
| SECONDARY Lesion Morphology - Contour as a Lesion Characteristic |
20; 5 | — |
| SECONDARY Lesion Morphology - Bifurcation (Branch or Division of Artery) |
0; 25 | — |
| SECONDARY Participants With Device-related Complications During Procedure |
0; 25 | — |
| SECONDARY Participants With Procedure-related Complications During Procedure |
0; 25 | — |
Summary
This is a Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA® in Treatment of Patients with Single or Multivessel Coronary Artery Disease (CAD). Up to 30 patients will be enrolled at up to 05 Indian study sites. Patients will be followed from enrollment through 30 days ± 7 days for the effectiveness and safety endpoints at the study centre.
Eligibility Criteria
Inclusion Criteria
- Have at least one severely stenotic lesion (greater than or equal to 80% diameter stenosis as assessed by visual estimation)
- Haemodynamically stable patients coming to the site for cardiac catheterization and angiography for various indications and who fulfill all the following criteria:
- Have no clinically significant cardiac arrhythmias, based on ECG results
- Have no evidence of valvular pathology, based on echocardiogram results
- Have ≥30% left ventricular ejection fraction (LVEF), based on echocardiogram results.
- Angiographic evidence of calcification or a chronic total occlusion
- Vessel reference diameter greater than or equal to 2.0 mm
- Patient is willing and able to comply with study requirements
- Women of child bearing potential, willing to use at least two methods of contraception
Exclusion Criteria
- Evidence of acute coronary syndrome within 3 months prior to index procedure
- Evidence of acute ischemic events
- Cardiogenic and non-cardiogenic shock
- Active bleeding or coagulopathy
- Previous coronary angioplasty within 6 months of the index procedure
- Patients participating in trial for another investigational device/medicine within 1 month prior to enrolment in this study
- Acute or Chronic renal failure, Impaired renal function (serum creatinine > 2.5 mg/dl or 221 umol/l) determined within 72 hours prior to index procedure.
- Known allergies to the following: Aspirin, Clopidogrel or Ticlopidine, Heparin, Sirolimus or its derivatives, contrast agent (that cannot be adequately pre-medicated), or any metal
- Planned surgery within 6 months of enrollment in this study
- Life expectancy less than 6 months
- Patients known to be suffering from substance abuse (alcohol or drug)
- Patients with any other significant co-morbid illness which in the opinion of the investigator is not conducive of inclusion in the study.
- Known or suspected Pregnancy
- Patients not willing to provide written informed consent
- In the investigators opinion subjects will not be able to comply with the follow-up requirements.
Data sourced from ClinicalTrials.gov (NCT03284229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.