Coronary Artery Disease
Conditions
Keywords
Intravascular Lithotripsy, Percutaneous Coronary Intervention
Brief 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.
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.
Interventions
DEVICEShockwave Medical Coronary IVL System
Coronary Intravascular Lithotripsy (IVL)
Sponsors
Shockwave Medical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject is a non-pregnant female ≥18 years of age 2. The subject meets indications for PCI and stent 3. The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion 4. The subject is willing to comply with protocol-specified follow-up evaluations 5. 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)
Exclusion criteria
1. 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 2. Subjects presenting with cardiogenic shock at the time of the index procedure 3. 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 4. Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines 5. Subject is enrolled in any study of an investigational device or drug that may interfere with study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF) | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic Success (≤30% Residual Stenosis) | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure | Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications. |
| Procedural Success | 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 stenosis \<50% in all target lesions (core laboratory assessed) and without in-hospital TLF. |
| Angiographic Success (< 50% Residual Stenosis) | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure | Angiographic Success defined as stent delivery with \< 50% residual stenosis and without serious angiographic complications. |
| Serious Angiographic Complications | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure | Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. |
| Target Lesion Failure (TLF)-1 Year | 1 year post procedure | 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) |
| Target Lesion Failure (TLF)- 2 Year | 2 years post procedure | 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) |
| Target Lesion Failure (TLF)- 3 Year | 3 years post procedure | 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) |
| Major Adverse Cardiac Events (MACE)- 30 Days | within 30 days of index procedure | 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. |
| Major Adverse Cardiac Events (MACE)- 1 Year | 1 year post procedure | 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. |
| Major Adverse Cardiac Events (MACE)- 2 Year | 2 years post procedure | 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. |
| Major Adverse Cardiac Events (MACE)- 3 Year | 3 years post procedure | 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. |
| 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 | 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) in-hospital |
| 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 | 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)- 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, and Stent Thrombosis- 1 Year | 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) |
| 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 | 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) |
| 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 | 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) |
| MI (Myocardial Infarction)- Discharge | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure | MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI. |
| MI (Myocardial Infarction)- 30 Day | within 30 days of index procedure | MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI. |
| MI (Myocardial Infarction)- 1 Year | 1 year post procedure | MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI. |
| MI (Myocardial Infarction)- 2 Year | 2 years post procedure | MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI. |
| MI (Myocardial Infarction)- 3 Year | 3 years post procedure | MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI. |
| Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 30 Days | From baseline to within 30 days of index procedure | 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. |
| Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 1 Year | From baseline to within 1 year of index procedure | 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. |
| Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 2 Years | From baseline to within 2 years of index procedure | 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. |
| Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 3 Years | From baseline to within 3 years of index procedure | 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. |
| Quality of Life Assessed by EQ-5D-5L- Baseline to 30 Days | From baseline to within 30 days of index procedure | 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. |
| Quality of Life Assessed by EQ-5D-5L- Baseline to 1 Year | From baseline to within 1 year of index procedure | 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. |
| Quality of Life Assessed by EQ-5D-5L- Baseline to 2 Year | From baseline to within 2 years of index procedure | 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. |
| Quality of Life Assessed by EQ-5D-5L- Baseline to 3 Year | From baseline to within 3 years of index procedure | 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. |
| Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 30 Day | From baseline to within 30 days of index procedure | 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). |
| Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 1 Year | From baseline to within 1 year of index procedure | 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). |
| Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 2 Year | From baseline to within 2 years of index procedure | 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). |
| Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 3 Year | From baseline to within 3 years of index procedure | 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). |
Countries
France, Germany, Spain, United Kingdom, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 73.1 years STANDARD_DEVIATION 9.9 |
| BMI Categories Healthy weight (18.5 - 24.9) | 126 Participants |
| BMI Categories Obesity (30 or greater) | 123 Participants |
| BMI Categories Overweight (25 - 29.9) | 140 Participants |
| BMI Categories Underweight (below 18.5) | 9 Participants |
| Body Mass Index | 27.9 kg/m2 STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 299 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 43 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 41 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized Unknown/Not specified | 23 Participants |
| Race/Ethnicity, Customized White | 319 Participants |
| Sex: Female, Male Female | 399 Participants |
| Sex: Female, Male Male | 0 Participants |
| Subject has Childbearing Potential | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 399 |
| other Total, other adverse events | 21 / 399 |
| serious Total, serious adverse events | 88 / 399 |
Outcome results
None listed