Coronary Artery DiseaseELCA-CADNCT03284229
Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD
A study testing Excimer Laser Coronary Atherectomy in people with Coronary Artery Disease, run by Spectranetics Corporation at 5 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Excimer Laser Coronary Atherectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesIndia
- Study dates
- 20 Sep 2017to 21 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Lilavati Hospital and Research Centre
Bandra, Mumbai, 100050
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bangalore, Karnataka, 560069
Global Health Private Limited, Medanta - The Medicity
Gurgaon, Haryana, 122001
Escorts Heart Institute & Research Centre Limited
New Delhi, National Capital Territory of Delhi, 160011
All Indian Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi
About this study
Official title: 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)
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.
Read the detailed description
Each subject will be followed from enrollment through 30 days ± 7 days for the effectiveness and safety endpoints. Upon enrollment after obtaining a written informed consent, each patient will be assigned a unique identification number. Only patients eligible to undergo cardiac catheterizations as per routine practice will be considered for the study. Premedication of patients will be as per the investigator's routine practice. All patient data will be recorded on patient data forms.
Screening: This will be performed prior to the cardiac catheterization procedure. Only patients who have consented and fulfill the selection criteria will be enrolled. Additionally, ECG and Echocardiogram will be done using hospital equipment to ensure fulfillment of inclusion/exclusion criteria.
Procedure: The entire procedure will be carried out as per the site routine practice and the device will be used as per the IFU.
Clinic follow up visit (30 ± 7 days): The subject will return to the clinic at 1 month to evaluate angina status as per the CCS classification, AE assessments, concomitant medications and any coronary intervention that has occurred since the previous contact.
An electrocardiogram (ECG) will be repeated during the clinic visit.
- Conditions
- Coronary Artery Disease
- Being tested
- Excimer Laser Coronary Atherectomy
- Keywords
- ELCA, Coronary Artery Disease, India
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer Laser Coronary AtherectomyDevice
Also called ELCA Coronary Laser Atherectomy Catheters (OTW and RX)
Excimer Laser Coronary Atherectomy (ELCA ®) uses the high energy, monochromatic light beam to alter or dissolve (vaporize) the plaque without damaging the surrounding tissue. Fiber-optic catheters are used to deliver this light beam. For endovascular applications, Xenon Chloride excimer laser is used and its fiber-optic catheter has multiple small fibers, rather than just a few large fibers, in order to be flexible enough to navigate in the arterial tree.
| Study group | Role | What they receive |
|---|---|---|
| Excimer Laser Coronary Atherectomy | Experimental | ELCA® in patients with single or multivessel CAD either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA). The entire procedure will be carried out as per the site routine practice and the device will be used as per the 'Instruction for Use'. Treating physicians/study investigators will be trained by the study Sponsor on the study protocol and procedures prior to clinical investigation procedure. Subject preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. Receives: Device: Excimer Laser Coronary Atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion
Successful crossing of the Laser Catheter across the entire length of the stenotic lesion
Measured: Procedure
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.
Measured: Procedure
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
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.
Measured: 30 days
Secondary outcomes (7)
TIMI Flow
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.
Measured: pre-procedure and post-procedure
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity
Tortuosity from coronary angiography
Measured: Procedure
Lesion Morphology - Eccentricity of Coronary Lesion
Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)
Measured: Procedure
Lesion Morphology - Contour as a Lesion Characteristic
Contour from coronary angiography
Measured: Procedure
Lesion Morphology - Bifurcation (Branch or Division of Artery)
Bifurcation from coronary angiography
Measured: Procedure
Participants With Device-related Complications During Procedure
To determine device related complications
Measured: Procedure
Participants With Procedure-related Complications During Procedure
To determine procedure related complications
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start20 Sep 2017
- Primary completion21 May 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As per the 25th SEC (Cardiovascular \& Renal) meeting which deliberated the proposals on 30-10-2015 and recommended the firm (Spectranetics Corporation - Sponsor) shall conduct a Bridging study in Indian Population at least 25 patients with coronary artery disease. The directorate suggested that the sponsor submit a protocol for the study in India for clinical trial approval. Considering the 5 dropouts, Sponsor has set up this protocol to conduct the Excimer Laser Coronary Atherectomy (ELCA®) study in India on 30 eligible patients across 05 sites as a Stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA) in single or multi-vessel coronary artery disease.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC-VIBGYOR Research Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Karen Krygier, MBA, Study director, Spectranetics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284229
- Sponsor's protocol ID
- ELCA-1016
- Acronym
- ELCA-CAD
- Status last verified
- Jul 2020
- First submitted
- 8 Sep 2017
- Last updated
- 18 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03284229
- Acronym / sponsor ID
- ELCA-CAD / ELCA-1016
- Conditions
- Coronary Artery Disease
- Keywords
- ELCA, Coronary Artery Disease, India
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- CBCC-VIBGYOR Research Pvt. Ltd.
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Posted 18 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each subject will be followed from enrollment through 30 days ± 7 days for the effectiveness and safety endpoints. Upon enrollment after obtaining a written informed consent, each patient will be assigned a unique identification number. Only patients eligible to undergo cardiac catheterizations as per routine practice will be considered for the study. Premedication of patients will be as per the investigator's routine practice. All patient data will be recorded on patient data forms.
Screening: This will be performed prior to the cardiac catheterization procedure. Only patients who have consented and fulfill the selection criteria will be enrolled. Additionally, ECG and Echocardiogram will be done using hospital equipment to ensure fulfillment of inclusion/exclusion criteria.
Procedure: The entire procedure will be carried out as per the site routine practice and the device will be used as per the IFU.
Clinic follow up visit (30 ± 7 days): The subject will return to the clinic at 1 month to evaluate angina status as per the CCS classification, AE assessments, concomitant medications and any coronary intervention that has occurred since the previous contact.
An electrocardiogram (ECG) will be repeated during the clinic visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As per the 25th SEC (Cardiovascular \& Renal) meeting which deliberated the proposals on 30-10-2015 and recommended the firm (Spectranetics Corporation - Sponsor) shall conduct a Bridging study in Indian Population at least 25 patients with coronary artery disease. The directorate suggested that the sponsor submit a protocol for the study in India for clinical trial approval. Considering the 5 dropouts, Sponsor has set up this protocol to conduct the Excimer Laser Coronary Atherectomy (ELCA®) study in India on 30 eligible patients across 05 sites as a Stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA) in single or multi-vessel coronary artery disease.
| Arm | Type | Receives |
|---|---|---|
| Excimer Laser Coronary Atherectomy | Experimental | Device: Excimer Laser Coronary AtherectomyELCA® in patients with single or multivessel CAD either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA). The entire procedure will be carried out as per the site routine practice and the device will be used as per the 'Instruction for Use'. Treating physicians/study investigators will be trained by the study Sponsor on the study protocol and procedures prior to clinical investigation procedure. Subject preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excimer Laser Coronary AtherectomyAlso: ELCA Coronary Laser Atherectomy Catheters (OTW and RX)Excimer Laser Coronary Atherectomy (ELCA ®) uses the high energy, monochromatic light beam to alter or dissolve (vaporize) the plaque without damaging the surrounding tissue. Fiber-optic catheters are used to deliver this light beam. For endovascular applications, Xenon Chloride excimer laser is used and its fiber-optic catheter has multiple small fibers, rather than just a few large fibers, in order to be flexible enough to navigate in the arterial tree. | Device | Excimer Laser Coronary Atherectomy |
Primary outcome
Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion
Time frame: Procedure
Successful crossing of the Laser Catheter across the entire length of the stenotic lesion
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
Time frame: Procedure
Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.
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
Time frame: 30 days
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.
7 secondary outcomes
TIMI Flow
Time frame: pre-procedure and post-procedure
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity
Time frame: Procedure
Lesion Morphology - Eccentricity of Coronary Lesion
Time frame: Procedure
Lesion Morphology - Contour as a Lesion Characteristic
Time frame: Procedure
Lesion Morphology - Bifurcation (Branch or Division of Artery)
Time frame: Procedure
Participants With Device-related Complications During Procedure
Time frame: Procedure
Participants With Procedure-related Complications During Procedure
Time frame: Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ELCA laser system and catheter IFUsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Krygier, MBA study director
Spectranetics Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excimer Laser Coronary Atherectomy in people with Coronary Artery Disease, run by Spectranetics Corporation at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion (time frame: Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020; AzTrials last refreshed its copy on 30 Oct 2026.