Coronary Artery DiseaseEMPOWER CADNCT05755711
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Shockwave Medical, Inc. at 49 sites in 5 countries.
Trial summary
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Shockwave Medical Coronary IVL System
- Type of treatment
- Medical device
- How many people
- 399 participants
- Where
- 49 sitesin 5 countries
- Study dates
- 3 May 2023to Apr 2028
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.
Who may be able to join
- The subject is a non-pregnant female ≥18 years of age
- The subject meets indications for PCI and stent
- The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion
- The subject is willing to comply with protocol-specified follow-up evaluations
- The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Who cannot join
- Subjects with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
- Subjects presenting with cardiogenic shock at the time of the index procedure
- Serious angiographic complication in the target vessel prior to treatment with coronary IVL including-severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflow
- Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines
- Subject is enrolled in any study of an investigational device or drug that may interfere with study results
Trial locations and contacts
49 sites in 5 countries.
49 sites in 5 countries
United States34 sites
Emory Hospital
Atlanta, Georgia, 30308
Piedmont Heart Institute
Atlanta, Georgia, 30309
Northside Hospital
Atlanta, Georgia, 30342
Overlake Medical Center
Bellevue, Washington, 98004
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
NYU Langone Health
Brooklyn, New York, 11220
MUSC Health University Medical Center
Charleston, South Carolina, 29425
The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy
Cincinnati, Ohio, 45219
Morton Plant Hospital
Clearwater, Florida, 33756
Northwestern University
Evanston, Illinois, 60208
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
University of Kansas Medical Center
Kansas City, Kansas, 66160
South Denver Cardiology Associates, P.C
Littleton, Colorado, 80120
Loma Linda University Health
Loma Linda, California, 92354
Good Samaritan Hospital
Los Angeles, California, 90017
New England Heart and Vascular Institute
Manchester, New Hampshire, 03102
DHR Health Heart Institute
McAllen, Texas, 78503
Centennial Heart
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale New Haven Hospital
New Haven, Connecticut, 06510
Tulane University Center for Clinical Research
New Orleans, Louisiana, 70112
NYU Langone Health
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
Baylor Scott & White Research Institute
Plano, Texas, 75093
Rhode Island Hospital
Providence, Rhode Island, 02903
St. Francis Hospital
Roslyn, New York, 11576
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, 94118
University of Washington Medical Center
Seattle, Washington, 98195
Stanford University
Stanford, California, 94305
Tallahassee Research Institute
Tallahassee, Florida, 32308
Montefiore Medical Center
The Bronx, New York, 10467
WellSpan York Hospital
York, Pennsylvania, 17403
France4 sites
Centre Hospitalier d'Antibes
Antibes, Antibes, 06606
Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier
Massy, 91300
AP-HP Hopital Pitie-Salpetriere
Paris, Paris, 75013
Clinique Pasteur
Toulouse, BP 27617, 31076 Cedex 3
Spain4 sites
Hospital del Mar
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Hospital Clínico San Carlos
Madrid
Hospital Clinico De Santiago
Santiago de Compostela, A Coruña
United Kingdom4 sites
Golden Jubilee National Hospital
Clydebank, G81 4HX
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
St. George's Hospital
London, SW17 0QT
Hammersmith Hospital
London, W12 0HS,
Germany3 sites
Heart and Lung Center Leipzig
Leipzig
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Mainz, Langenbeckstr. 1, 55131
Krankenhaus der Barmherzigen Bruder Trier
Trier, Nordallee 1, 54292
About this study
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
Read the detailed description
Subject population: up to 400 female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care at up to 50 global sites in the US, UK and Europe. Subjects will have clinical follow-up prior to discharge from the index intervention and at 30 days, 1, 2 and 3 years.
- Conditions
- Coronary Artery Disease
- Being tested
- Shockwave Medical Coronary IVL System
- Keywords
- Intravascular Lithotripsy, Percutaneous Coronary Intervention
- 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.
Shockwave Medical Coronary IVL SystemDevice
Coronary Intravascular Lithotripsy (IVL)
| Study group | Role | What they receive |
|---|---|---|
| Female subjects referred for percutaneous coronary intervention | Female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care. Receives: Device: Shockwave Medical Coronary IVL System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF)
Target lesion failure (TLF) at 30 days defined as a composite of cardiac death, myocardial infarction (per SCAI definition for peri-procedural MI; per 4th Universal Definition for spontaneous MI beyond discharge) attributable to target vessel (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR).
Measured: within 30 days of index procedure
Primary Effectiveness Endpoint: Procedural Success
Procedural Success defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions (core laboratory assessed) and without in-hospital TLF (CEC adjudicated).
Measured: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Secondary outcomes (33)
Angiographic Success (≤30% Residual Stenosis)
Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.
Measured: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Procedural Success
Procedural Success defined as stent delivery with a residual stenosis <50% in all target lesions (core laboratory assessed) and without in-hospital TLF.
Measured: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Angiographic Success (< 50% Residual Stenosis)
Angiographic Success defined as stent delivery with < 50% residual stenosis and without serious angiographic complications.
Measured: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Serious Angiographic Complications
Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Measured: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Target Lesion Failure (TLF)-1 Year
TFL is defined as a composite of:
- Cardiac death (see definition within this definition of terms), or
- Myocardial Infarction (per SCAI definition for peri-procedural MI; or per Fourth Universal definition for spontaneous MI beyond discharge)-see definition within this definition of terms), or
- Ischemia-driven target lesion revascularization-ID-TLR (see definition within this definition of terms)
Measured: 1 year post procedure
Target Lesion Failure (TLF)- 2 Year
TFL is defined as a composite of:
- Cardiac death (see definition within this definition of terms), or
- Myocardial Infarction (per SCAI definition for peri-procedural MI; or per Fourth Universal definition for spontaneous MI beyond discharge)-see definition within this definition of terms), or
- Ischemia-driven target lesion revascularization-ID-TLR (see definition within this definition of terms)
Measured: 2 years post procedure
Target Lesion Failure (TLF)- 3 Year
TFL is defined as a composite of:
- Cardiac death (see definition within this definition of terms), or
- Myocardial Infarction (per SCAI definition for peri-procedural MI; or per Fourth Universal definition for spontaneous MI beyond discharge)-see definition within this definition of terms), or
- Ischemia-driven target lesion revascularization-ID-TLR (see definition within this definition of terms)
Measured: 3 years post procedure
Major Adverse Cardiac Events (MACE)- 30 Days
Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, myocardial infarction (per SCAI definition for periprocedural MI; per 4th Universal Definition for spontaneous MI beyond discharge), and target vessel revascularization. All MACE were adjudicated by an independent CEC.
Measured: within 30 days of index procedure
Major Adverse Cardiac Events (MACE)- 1 Year
Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, myocardial infarction (per SCAI definition for periprocedural MI; per 4th Universal Definition for spontaneous MI beyond discharge), and target vessel revascularization. All MACE were adjudicated by an independent CEC.
Measured: 1 year post procedure
Major Adverse Cardiac Events (MACE)- 2 Year
Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, myocardial infarction (per SCAI definition for periprocedural MI; per 4th Universal Definition for spontaneous MI beyond discharge), and target vessel revascularization. All MACE were adjudicated by an independent CEC.
Measured: 2 years post procedure
Major Adverse Cardiac Events (MACE)- 3 Year
Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, myocardial infarction (per SCAI definition for periprocedural MI; per 4th Universal Definition for spontaneous MI beyond discharge), and target vessel revascularization. All MACE were adjudicated by an independent CEC.
Measured: 3 years post procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- Discharge
All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) in-hospital
Measured: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure.
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 30 Days
All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)- 30 days
Measured: within 30 days of index procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 1 Year
All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)
Measured: 1 year post procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 2 Year
All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)
Measured: 2 years post procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 3 Year
All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)
Measured: 3 years post procedure
MI (Myocardial Infarction)- Discharge
MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.
Measured: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
MI (Myocardial Infarction)- 30 Day
MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.
Measured: within 30 days of index procedure
MI (Myocardial Infarction)- 1 Year
MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.
Measured: 1 year post procedure
MI (Myocardial Infarction)- 2 Year
MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.
Measured: 2 years post procedure
MI (Myocardial Infarction)- 3 Year
MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.
Measured: 3 years post procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 30 Days
Angina symptoms assessed as a change from baseline by Seattle Angina Questionnaire (SAQ-7). Summary score; 0 to 24 represents poor health status; 25 to 49 represents fair; 50 to 74 represents good; 75 to 100 represents excellent.
Measured: From baseline to within 30 days of index procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 1 Year
Angina symptoms assessed as a change from baseline by Seattle Angina Questionnaire (SAQ-7). Summary score; 0 to 24 represents poor health status; 25 to 49 represents fair; 50 to 74 represents good; 75 to 100 represents excellent.
Measured: From baseline to within 1 year of index procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 2 Years
Angina symptoms assessed as a change from baseline by Seattle Angina Questionnaire (SAQ-7). Summary score; 0 to 24 represents poor health status; 25 to 49 represents fair; 50 to 74 represents good; 75 to 100 represents excellent.
Measured: From baseline to within 2 years of index procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 3 Years
Angina symptoms assessed as a change from baseline by Seattle Angina Questionnaire (SAQ-7). Summary score; 0 to 24 represents poor health status; 25 to 49 represents fair; 50 to 74 represents good; 75 to 100 represents excellent.
Measured: From baseline to within 3 years of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 30 Days
Quality of life assessed by EQ-5D-5L as a change from baseline. Summary score; ranges from 0-100; 100 represents the best health you can imagine; 0 represents the worst.
Measured: From baseline to within 30 days of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 1 Year
Quality of life assessed by EQ-5D-5L as a change from baseline. Summary score; ranges from 0-100; 100 represents the best health you can imagine; 0 represents the worst.
Measured: From baseline to within 1 year of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 2 Year
Quality of life assessed by EQ-5D-5L as a change from baseline. Summary score; ranges from 0-100; 100 represents the best health you can imagine; 0 represents the worst.
Measured: From baseline to within 2 years of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 3 Year
Quality of life assessed by EQ-5D-5L as a change from baseline. Summary score; ranges from 0-100; 100 represents the best health you can imagine; 0 represents the worst.
Measured: From baseline to within 3 years of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 30 Day
Quality of life assessed by Generalized Anxiety Disorder Questionnaire (GAD-7) as a change from baseline. Total score calculated by summing points (0-3) for each of the seven questions, yielding a total score from 0-21 (at each time period). Minimal Anxiety (0-4); Mild Anxiety (5-9 ); Moderate Anxiety (10-14 ); Severe Anxiety (≥15).
Measured: From baseline to within 30 days of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 1 Year
Quality of life assessed by Generalized Anxiety Disorder Questionnaire (GAD-7) as a change from baseline. Total score calculated by summing points (0-3) for each of the seven questions, yielding a total score from 0-21 (at each time period). Minimal Anxiety (0-4); Mild Anxiety (5-9 ); Moderate Anxiety (10-14 ); Severe Anxiety (≥15).
Measured: From baseline to within 1 year of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 2 Year
Quality of life assessed by Generalized Anxiety Disorder Questionnaire (GAD-7) as a change from baseline. Total score calculated by summing points (0-3) for each of the seven questions, yielding a total score from 0-21 (at each time period). Minimal Anxiety (0-4); Mild Anxiety (5-9 ); Moderate Anxiety (10-14 ); Severe Anxiety (≥15).
Measured: From baseline to within 2 years of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 3 Year
Quality of life assessed by Generalized Anxiety Disorder Questionnaire (GAD-7) as a change from baseline. Total score calculated by summing points (0-3) for each of the seven questions, yielding a total score from 0-21 (at each time period). Minimal Anxiety (0-4); Mild Anxiety (5-9 ); Moderate Anxiety (10-14 ); Severe Anxiety (≥15).
Measured: From baseline to within 3 years of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start3 May 2023
- Primary completion11 Dec 2024
- Study completionApr 2028 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755711
- Sponsor's protocol ID
- CP 67712
- Acronym
- EMPOWER CAD
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2023
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05755711
- Acronym / sponsor ID
- EMPOWER CAD / CP 67712
- Conditions
- Coronary Artery Disease
- Keywords
- Intravascular Lithotripsy, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2023 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- Apr 2028 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
Detailed description
Subject population: up to 400 female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care at up to 50 global sites in the US, UK and Europe. Subjects will have clinical follow-up prior to discharge from the index intervention and at 30 days, 1, 2 and 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female subjects referred for percutaneous coronary intervention | – | Device: Shockwave Medical Coronary IVL SystemFemale subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.
Key inclusion criteria (5 listed)
- The subject is a non-pregnant female ≥18 years of age
- The subject meets indications for PCI and stent
- The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion
- The subject is willing to comply with protocol-specified follow-up evaluations
- The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Key exclusion criteria (5 listed)
- Subjects with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
- Subjects presenting with cardiogenic shock at the time of the index procedure
- Serious angiographic complication in the target vessel prior to treatment with coronary IVL including-severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflow
- Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines
- Subject is enrolled in any study of an investigational device or drug that may interfere with study results
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 |
|---|---|---|
| Shockwave Medical Coronary IVL SystemCoronary Intravascular Lithotripsy (IVL) | Device | Female subjects referred for percutaneous coronary intervention |
Primary outcome
Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF)
Time frame: within 30 days of index procedure
Target lesion failure (TLF) at 30 days defined as a composite of cardiac death, myocardial infarction (per SCAI definition for peri-procedural MI; per 4th Universal Definition for spontaneous MI beyond discharge) attributable to target vessel (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR).
Primary Effectiveness Endpoint: Procedural Success
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Procedural Success defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions (core laboratory assessed) and without in-hospital TLF (CEC adjudicated).
33 secondary outcomes
Angiographic Success (≤30% Residual Stenosis)
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Procedural Success
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Angiographic Success (< 50% Residual Stenosis)
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Serious Angiographic Complications
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Target Lesion Failure (TLF)-1 Year
Time frame: 1 year post procedure
Target Lesion Failure (TLF)- 2 Year
Time frame: 2 years post procedure
Target Lesion Failure (TLF)- 3 Year
Time frame: 3 years post procedure
Major Adverse Cardiac Events (MACE)- 30 Days
Time frame: within 30 days of index procedure
Major Adverse Cardiac Events (MACE)- 1 Year
Time frame: 1 year post procedure
Major Adverse Cardiac Events (MACE)- 2 Year
Time frame: 2 years post procedure
Major Adverse Cardiac Events (MACE)- 3 Year
Time frame: 3 years post procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- Discharge
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure.
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 30 Days
Time frame: within 30 days of index procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 1 Year
Time frame: 1 year post procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 2 Year
Time frame: 2 years post procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 3 Year
Time frame: 3 years post procedure
MI (Myocardial Infarction)- Discharge
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
MI (Myocardial Infarction)- 30 Day
Time frame: within 30 days of index procedure
MI (Myocardial Infarction)- 1 Year
Time frame: 1 year post procedure
MI (Myocardial Infarction)- 2 Year
Time frame: 2 years post procedure
MI (Myocardial Infarction)- 3 Year
Time frame: 3 years post procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 30 Days
Time frame: From baseline to within 30 days of index procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 1 Year
Time frame: From baseline to within 1 year of index procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 2 Years
Time frame: From baseline to within 2 years of index procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 3 Years
Time frame: From baseline to within 3 years of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 30 Days
Time frame: From baseline to within 30 days of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 1 Year
Time frame: From baseline to within 1 year of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 2 Year
Time frame: From baseline to within 2 years of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 3 Year
Time frame: From baseline to within 3 years of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 30 Day
Time frame: From baseline to within 30 days of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 1 Year
Time frame: From baseline to within 1 year of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 2 Year
Time frame: From baseline to within 2 years of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 3 Year
Time frame: From baseline to within 3 years of index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shockwave Medical, Inc. at 49 sites in 5 countries.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, France, Spain, United Kingdom, Germany. 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 22 Jan 2026). 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?
Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF) (time frame: within 30 days of index procedure). The study lists 2 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 30 Jul 2026.