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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female subjects referred for percutaneous coronary intervention | Female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Medical Coronary IVL System | Device | Coronary Intravascular Lithotripsy (IVL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic Success (≤30% Residual Stenosis) | Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications. | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure |
| Procedural Success |
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Inclusion Criteria:
Exclusion Criteria:
The subject is a non-pregnant female ≥18 years of age, (female sex assigned at birth)
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Female patients referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Loma Linda | California | 92354 | United States | ||
| Good Samaritan Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intent to Treat | The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2023 |
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Procedural Success defined as stent delivery with a residual stenosis <50% in all target lesions (core laboratory assessed) and without in-hospital TLF. |
| 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. | 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. | 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:
| 1 year post procedure |
| Target Lesion Failure (TLF)- 2 Year | TFL is defined as a composite of:
| 2 years post procedure |
| Target Lesion Failure (TLF)- 3 Year | TFL is defined as a composite of:
| 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. | 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. | 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. | 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. | 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 | 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 | 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) | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | From baseline to within 3 years of index procedure |
| Los Angeles |
| California |
| 90017 |
| United States |
| Kaiser Permanente - San Francisco Medical Center | San Francisco | California | 94118 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| South Denver Cardiology Associates, P.C | Littleton | Colorado | 80120 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| Emory Hospital | Atlanta | Georgia | 30308 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Tulane University Center for Clinical Research | New Orleans | Louisiana | 70112 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| New England Heart and Vascular Institute | Manchester | New Hampshire | 03102 | United States |
| NYU Langone Health | Brooklyn | New York | 11220 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy | Cincinnati | Ohio | 45219 | United States |
| WellSpan York Hospital | York | Pennsylvania | 17403 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| MUSC Health University Medical Center | Charleston | South Carolina | 29425 | United States |
| Centennial Heart | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| DHR Health Heart Institute | McAllen | Texas | 78503 | United States |
| Baylor Scott & White Research Institute | Plano | Texas | 75093 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| Overlake Medical Center | Bellevue | Washington | 98004 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Clinique Pasteur | Toulouse | BP 27617 | 31076 Cedex 3 | France |
| AP-HP Hopital Pitie-Salpetriere | Paris | Paris | 75013 | France |
| Centre Hospitalier d'Antibes | Antibes | 06606 | France |
| Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier | Massy | 91300 | France |
| Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz | Mainz | Langenbeckstr. 1 | 55131 | Germany |
| Krankenhaus der Barmherzigen Bruder Trier | Trier | Nordallee 1 | 54292 | Germany |
| Heart and Lung Center Leipzig | Leipzig | Germany |
| Hospital Clinico De Santiago | Santiago de Compostela | A Coruña | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Golden Jubilee National Hospital | Clydebank | G81 4HX | United Kingdom |
| Liverpool Heart and Chest Hospital | Liverpool | L14 3PE | United Kingdom |
| St. George's Hospital | London | SW17 0QT | United Kingdom |
| Hammersmith Hospital | London | W12 0HS, | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intent-to-Treat (ITT) | The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Subject has Childbearing Potential | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index | N=398 because 1 participant did not have a have a height measurement to calculate BMI | Mean | Standard Deviation | kg/m2 |
| ||||||||||||||||
| BMI Categories | N=398 because 1 participant did not have a have a height measurement to calculate BMI | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | within 30 days of index procedure |
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| Primary | 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). | Posted | Count of Participants | Participants | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure |
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| Secondary | Angiographic Success (≤30% Residual Stenosis) | Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications. | Posted | Count of Units | Lesions | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure | Lesions | Lesions |
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| Secondary | 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. | Posted | Count of Participants | Participants | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure |
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| Secondary | Angiographic Success (< 50% Residual Stenosis) | Angiographic Success defined as stent delivery with < 50% residual stenosis and without serious angiographic complications. | Posted | Count of Units | Lesions | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure | Lesions | Lesions |
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| Secondary | 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. | Posted | Count of Units | Lesions | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure | Lesions | Lesions |
|
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| Secondary | Target Lesion Failure (TLF)-1 Year | TFL is defined as a composite of:
| Not Posted | Jan 2027 | 1 year post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | Target Lesion Failure (TLF)- 2 Year | TFL is defined as a composite of:
| Not Posted | Jan 2028 | 2 years post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | Target Lesion Failure (TLF)- 3 Year | TFL is defined as a composite of:
| Not Posted | Jan 2029 | 3 years post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | within 30 days of index procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2027 | 1 year post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2028 | 2 years post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2029 | 3 years post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure. |
|
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| Secondary | 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 | Posted | Count of Participants | Participants | within 30 days of index procedure |
|
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| Secondary | 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) | Not Posted | Jan 2027 | 1 year post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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) | Not Posted | Jan 2028 | 2 years post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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) | Not Posted | Jan 2029 | 3 years post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | within 30 days of index procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2027 | 1 year post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2028 | 2 years post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2029 | 3 years post procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to within 30 days of index procedure |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2027 | From baseline to within 1 year of index procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2028 | From baseline to within 2 years of index procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2029 | From baseline to within 3 years of index procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | From baseline to within 30 days of index procedure |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2027 | From baseline to within 1 year of index procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2028 | From baseline to within 2 years of index procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Jan 2029 | From baseline to within 3 years of index procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to within 30 days of index procedure |
|
| |||||||||||||||||||||||||||
| Secondary | 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). | Not Posted | Jan 2027 | From baseline to within 1 year of index procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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). | Not Posted | Jan 2028 | From baseline to within 2 years of index procedure | Participants | ||||||||||||||||||||||||||||||
| Secondary | 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). | Not Posted | Jan 2029 | From baseline to within 3 years of index procedure | Participants |
30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intent to Treat (ITT) | The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects. | 8 | 399 | 88 | 399 | 21 | 399 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Coronary artery perforation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Vascular access site discharge | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Periprocedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 21.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arterial perforation | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Atherosclerotic plaque rupture | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Distributive shock | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
The study is a post-market observational study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding study results for a period that is more than 45 days but less than or equal to 90 days from the date that the communication is submitted to the sponsor for review. The sponsor cannot unilaterally extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracy Courtney | Shockwave Medical | 1.650.224.7699 | TCourtn4@its.jnj.com |
| Jan 14, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
|
| Unknown or Not Reported |
|
|
|
| Black or African American |
|
|
| Native Hawaiian or Other Pacific Islander |
|
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| White |
|
|
| Unknown/Not specified |
|
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| Other |
|
|
| Healthy weight (18.5 - 24.9) |
|
| Overweight (25 - 29.9) |
|
| Obesity (30 or greater) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Peri-procedural MI (<48hrs, SCAI Definition) |
| |||||
| Spontaneous MI (>48hrs, 4th Universal Definition: Type 4a) |
| |||||
| TLF (Target Lesion Failure) |
|
| Title | Denominators | Categories |
|---|
| Peri-procedural MI (<48hrs, SCAI Definition) |
| |||||
| Spontaneous MI (>48hrs, 4th Universal Definition: Type 4a) |
| |||||
| TLF (Target Lesion Failure) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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