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.
Study Type
OBSERVATIONAL
Enrollment
399
Coronary Intravascular Lithotripsy (IVL)
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).
Time frame: 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).
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Angiographic Success (≤30% Residual Stenosis)
Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.
Time frame: 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.
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)
Angiographic Success defined as stent delivery with \< 50% residual stenosis and without serious angiographic complications.
Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Loma Linda University Health
Loma Linda, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
South Denver Cardiology Associates, P.C
Littleton, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Morton Plant Hospital
Clearwater, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Emory Hospital
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
...and 39 more locations
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.
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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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
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
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
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
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)
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
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)
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
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)
Time frame: 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.
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
MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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).
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
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).
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
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).
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
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).
Time frame: From baseline to within 3 years of index procedure