Trial Outcomes & Findings for Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD (NCT NCT03284229)

Results Overview

Successful crossing of the Laser Catheter across the entire length of the stenotic lesion

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Procedure

Results posted on

2020-09-18

Participant Flow

31 patients were screened. 3 patients were screen failure. 28 patients enrolled in the study.

Participant milestones

Participant milestones
Measure	Enrolled Excimer Laser Coronary Atherectomy (ELCA) Enrolled Patients
Overall Study STARTED	28
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled Excimer Laser Coronary Atherectomy (ELCA) Enrolled Patients
Overall Study Lost to Follow-up	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled n=25 Participants Enrolled Patients
Age, Continuous	64.04 years STANDARD_DEVIATION 8.26 • n=25 Participants
Sex: Female, Male Female	6 Participants n=25 Participants
Sex: Female, Male Male	19 Participants n=25 Participants
Region of Enrollment India	25 participants n=25 Participants
Height	163.50 cms STANDARD_DEVIATION 8.68 • n=25 Participants
Weight	70.80 kgs STANDARD_DEVIATION 11.37 • n=25 Participants
Angina Class Class 0/I	3 Participants n=25 Participants
Angina Class Class II	17 Participants n=25 Participants
Angina Class Class III	4 Participants n=25 Participants
Angina Class Class IV	1 Participants n=25 Participants

PRIMARY outcome

Timeframe: Procedure

Successful crossing of the Laser Catheter across the entire length of the stenotic lesion

Outcome measures

Outcome measures
Measure	Enrolled n=25 Participants Enrolled Patients
Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion Success	25 Participants
Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion Failure	0 Participants

PRIMARY outcome

Timeframe: Procedure

Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.

Outcome measures

Outcome measures
Measure	Enrolled n=25 Participants Enrolled Patients
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure < 50%	25 Participants
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure ≥ 50%	0 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Safety success includes 25 subjects that completed follow up and 3 subjects that were Lost To Follow Up

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.

Outcome measures

Outcome measures
Measure	Enrolled n=28 Participants Enrolled Patients
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 No Major Adverse Cardiac Events	28 Participants
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 Death	0 Participants
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 Non-Q-wave	0 Participants
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 Q-wave myocardial infarction	0 Participants
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 Target Lesion Revascularization	0 Participants
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 Cardiac Tamponade	0 Participants
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 Life threatening arrhythmias	0 Participants

SECONDARY outcome

Timeframe: pre-procedure and post-procedure

To determine post-procedural TIMI Flow grade. Changes of TIMI Grade flow after Index Procedure by measuring pre-procedure TIMI grade flow and post-procedure TIMI grade flow. TIMI flow is a scoring system from 0-3 referring to levels of coronary blood flow assessed during percutaneous coronary angioplasty. TIMI flow was assessed before and after the procedure. TIMI grade flow 0-3 are as described below. * TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. * TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. * TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. * TIMI 3 is normal flow which fills the distal coronary bed completely.

Outcome measures

Outcome measures
Measure	Enrolled n=25 Participants Enrolled Patients
TIMI Flow Pre-Procedure TIMI grade flow · TIMI grade flow 0	0 Participants
TIMI Flow Pre-Procedure TIMI grade flow · TIMI grade flow 1	12 Participants
TIMI Flow Pre-Procedure TIMI grade flow · TIMI grade flow 2	9 Participants
TIMI Flow Pre-Procedure TIMI grade flow · TIMI grade flow 3	4 Participants
TIMI Flow Post Procedure TIMI grade flow · TIMI grade flow 0	0 Participants
TIMI Flow Post Procedure TIMI grade flow · TIMI grade flow 1	0 Participants
TIMI Flow Post Procedure TIMI grade flow · TIMI grade flow 2	0 Participants
TIMI Flow Post Procedure TIMI grade flow · TIMI grade flow 3	25 Participants

SECONDARY outcome

Timeframe: Procedure

Tortuosity from coronary angiography

Outcome measures

Outcome measures
Measure	Enrolled n=25 Participants Enrolled Patients
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity > 90°	3 Participants
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity < 45°	14 Participants
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity 45° - 90°	8 Participants

SECONDARY outcome

Timeframe: Procedure

Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)

Outcome measures

Outcome measures
Measure	Enrolled n=25 Participants Enrolled Patients
Lesion Morphology - Eccentricity of Coronary Lesion Concentric lesions	17 Participants
Lesion Morphology - Eccentricity of Coronary Lesion Eccentric lesions	8 Participants

SECONDARY outcome

Timeframe: Procedure

Contour from coronary angiography

Outcome measures

Outcome measures
Measure	Enrolled n=25 Participants Enrolled Patients
Lesion Morphology - Contour as a Lesion Characteristic Irregular Contour	20 Participants
Lesion Morphology - Contour as a Lesion Characteristic Smooth Contour	5 Participants

SECONDARY outcome

Timeframe: Procedure

Bifurcation from coronary angiography

Outcome measures

Outcome measures
Measure	Enrolled n=25 Participants Enrolled Patients
Lesion Morphology - Bifurcation (Branch or Division of Artery) Bifurcation	0 Participants
Lesion Morphology - Bifurcation (Branch or Division of Artery) No Bifurcation	25 Participants

SECONDARY outcome

Timeframe: Procedure

To determine device related complications

Outcome measures

Outcome measures
Measure	Enrolled n=25 Participants Enrolled Patients
Participants With Device-related Complications During Procedure Yes	0 Participants
Participants With Device-related Complications During Procedure No	25 Participants

SECONDARY outcome

Timeframe: Procedure

To determine procedure related complications

Outcome measures

Outcome measures
Measure	Enrolled n=25 Participants Enrolled Patients
Participants With Procedure-related Complications During Procedure Yes	0 Participants
Participants With Procedure-related Complications During Procedure No	25 Participants

Adverse Events

Enrolled

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Enrolled n=28 participants at risk Enrolled Patients, including LTFU
Investigations Cardiac troponin I increased	3.6% 1/28 • Number of events 1 • Adverse event data were collected throughout the clinical investigation in the case report form. Any adverse event will be followed until one month follow up visit. Adverse event definition and classification adapted from ISO 14155
Cardiac disorders Angina pectoris	3.6% 1/28 • Number of events 1 • Adverse event data were collected throughout the clinical investigation in the case report form. Any adverse event will be followed until one month follow up visit. Adverse event definition and classification adapted from ISO 14155
Cardiac disorders Dyspnoea exertional	3.6% 1/28 • Number of events 1 • Adverse event data were collected throughout the clinical investigation in the case report form. Any adverse event will be followed until one month follow up visit. Adverse event definition and classification adapted from ISO 14155

Additional Information

Spectranetics Corporation

Phone: 719-447-2211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place