Coronary Artery Disease (CAD)AERO CADNCT07512206
AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease
A study testing Shockwave C2 Aero Coronary IVL System in people with Coronary Artery Disease (CAD) and Coronary Calcification, run by OPCI Core Laboratories LLC at 8 sites in United States.
Trial summary
The AERO CAD study is a prospective, multi-center, single-arm, post-market clinical investigation evaluating the procedural performance and clinical outcomes of the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System in patients with calcified coronary artery disease undergoing percutaneous coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Coronary Calcification, Coronary Calcified Disease
- What is being tested?
- Shockwave C2 Aero Coronary IVL System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Apr 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patient undergoing percutaneous coronary intervention (PCI) for coronary artery disease
- Target lesion(s) intended for treatment with intravascular lithotripsy (IVL) and stent implantation per standard of care
- Ability to provide informed consent
- Willingness and ability to comply with study follow-up requirements
Who cannot join
- ST-elevation myocardial infarction (STEMI) at presentation
- Cardiogenic shock at time of procedure
- In-stent restenosis (ISR) target lesion
- Known contraindication to antiplatelet or anticoagulation therapy
- Known intolerance or contraindication to contrast media not amenable to premedication
- Participation in another investigational drug or device study that could interfere with the endpoints of this study
- Life expectancy <1 year
- Inability or unwillingness to comply with study procedures or follow-up
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Henry Ford St. John Hospital
Detroit, Michigan, 48236
Renee L Bess, BS, RDCS, RVT, CCRP, 313.343.4811, rbess1@hfhs.org
Amir Kaki, MD
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Anne DeToro, RN, BS, CCRC, 732-776-3499, annemarie.detoro@hmhn.org
Daniel H Kiss, MD
The Valley Hospital
Paramus, New Jersey, 07652
Sequoia L Young, MS, CIP, CIM, 201.389.0194, SYoung3@valleyhealth.com
Raj Tayal, MD
Baylor Scott & White Health - The Heart Hospital Plano
Plano, Texas, 75093
Walter Cerqueira, MS, CCRC, 469-814-3393, Walter.Cerqueira@bswhealth.org
Chadi Dib, MD
St Francis Hospital & Heart Center
Roslyn, New York, 11576
Ziad A Ali, MD DPhil, 6464501870, ziad.ali@dcvi.org
Evan S Shlofmitz, DO
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Mane Arabyan, 626-755-8946, Mane.Arabyan@hcahealthcare.com
Dhananjay Chatterjee, MD
Good Samaritan University Hospital
West Islip, New York, 11795
Jeffrey W Moses, MD, 6463398983, jeffrey.moses@chsli.org
WellSpan Health, York Hospital
York, Pennsylvania, 17403
Alexandra Harper, 717-851-5848, aharper2@wellspan.org
Rhian E Davies, DO, MS
About this study
Official title: AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease
The AERO CAD study is a prospective, multi-center, single-arm, post-market clinical investigation evaluating the procedural performance and clinical outcomes of the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System in patients with calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).
The study will enroll up to 200 subjects across up to 8 U.S. sites. The primary objective is to generate real-world evidence on device performance and clinical outcomes, including target lesion failure at 30 days and procedural success.
Read the detailed description
The AERO CAD study is designed to characterize real-world clinical performance and outcomes associated with the commercially available Shockwave C2 Aero Coronary IVL catheter.
Coronary artery calcification presents a major challenge during PCI, often leading to suboptimal stent expansion and adverse clinical outcomes. Intravascular lithotripsy (IVL) has emerged as a calcium modification technology that facilitates lesion preparation at low balloon pressures.
The C2 Aero IVL catheter represents a next-generation iteration with improved deliverability, lower profile, enhanced hydrophilic coating, and improved balloon durability. This study evaluates its use in routine clinical practice.
This is a prospective, single-arm, interventional post-market study enrolling patients undergoing PCI with IVL and stenting per standard of care. No additional procedures beyond standard clinical practice are required.
Subjects will be followed through discharge, 30 days, and 1 year.
- Conditions
- Coronary Artery Disease (CAD), Coronary Calcification, Coronary Calcified Disease, Coronary Calcified Nodules
- Being tested
- Shockwave C2 Aero Coronary IVL System
- Keywords
- Aero CAD, Aero IVL, IVL
- 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 C2 Aero Coronary IVL SystemDevice
Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - C2 Aero IVL | Other | Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement. Receives: Device: Shockwave C2 Aero Coronary IVL System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR)
Measured: 30 days
Procedural Success
Successful delivery of the IVL catheter, delivery of lithotripsy therapy, stent placement with ≤30% residual stenosis, and no in-hospital target lesion failure
Measured: During procedure / during hospitalization (up to 5 days)
Secondary outcomes (7)
Device Success
Successful delivery, inflation, and activation of the IVL catheter at the target lesion without device-related complications
Measured: Index procedure
Serious Angiographic Complications
Occurrence of major procedural complications including coronary perforation, severe dissection (≥Type C), abrupt closure, or no-reflow
Measured: Index procedure
IVL Device Utilization
Number of IVL catheters used per case and need for adjunctive devices (e.g., atherectomy, specialty balloons, guide extension)
Measured: Index procedure
Target Lesion Failure (TLF) at 1 Year
Composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization
Measured: 1 year
Individual Components of TLF
Rates of cardiac death, target vessel MI, and ischemia-driven TLR analyzed separately
Measured: 30 days and 1 year
Stent Thrombosis
Definite or probable stent thrombosis based on ARC criteria
Measured: 30 days and 1 year
All-Cause Mortality
Death from any cause
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OPCI Core Laboratories LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allen Jeremias, St. Francis Hospital, New York
- Investigators
- Allen Jeremias, MD, MSc, Principal investigator, St Francis Hospital & Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512206
- Sponsor's protocol ID
- OPCI-AERO-CAD-1.8-Rev D
- Acronym
- AERO CAD
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be publicly shared. De-identified data may be made available upon reasonable request and subject to applicable approvals and data use agreements.
Publications
Riley RF, Patel MP, Abbott JD, Bangalore S, Brilakis ES, Croce KJ, Doshi D, Kaul P, Kearney KE, Kerrigan JL, McEntegart M, Maehara A, Rymer JA, Sutton NR, Shah B. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions. J Soc Cardiovasc Angiogr Interv. 2024 Jan 31;3(2):101259. doi: 10.1016/j.jscai.2023.101259. eCollection 2024 Feb.
PubMed 39132214January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons. Circulation. 2019 Jul 9;140(2):e125-e151. doi: 10.1161/CIR.0000000000000665. Epub 2019 Jan 28. No abstract available.
PubMed 30686041Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available.
PubMed 27026020Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.
PubMed 28886622Cho L, Vest AR, O'Donoghue ML, Ogunniyi MO, Sarma AA, Denby KJ, Lau ES, Poole JE, Lindley KJ, Mehran R; Cardiovascular Disease in Women Committee Leadership Council. Increasing Participation of Women in Cardiovascular Trials: JACC Council Perspectives. J Am Coll Cardiol. 2021 Aug 17;78(7):737-751. doi: 10.1016/j.jacc.2021.06.022.
PubMed 34384555Hussain Y, Kearney KE, Abbott JD, Kereiakes DJ, Di Mario C, Saito S, Cristea E, Riley RF, Fajadet J, Shlofmitz RA, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW, Lansky AJ. Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies. J Soc Cardiovasc Angiogr Interv. 2022 Jan 30;1(1):100011. doi: 10.1016/j.jscai.2021.100011. eCollection 2022 Jan-Feb.
PubMed 39130137Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.
PubMed 33939604Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, Nakamura S, Shibata Y; Disrupt CAD IV Investigators. Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study. Circ J. 2021 May 25;85(6):826-833. doi: 10.1253/circj.CJ-20-1174. Epub 2021 Feb 5.
PubMed 33551398Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.
PubMed 33069849Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Gotberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531. No abstract available.
PubMed 30715944Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
PubMed 31553205Kereiakes DJ, Virmani R, Hokama JY, Illindala U, Mena-Hurtado C, Holden A, Hill JM, Lyden SP, Ali ZA. Principles of Intravascular Lithotripsy for Calcific Plaque Modification. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1275-1292. doi: 10.1016/j.jcin.2021.03.036.
PubMed 34167671Powers CJ, Tinterow MM, Burpee JF. Extracorporeal shock wave lithotripsy: a study of renal stone differences. Kans Med. 1989 Jan;90(1):19-22.
PubMed 2709649Choi KH, Song YB, Lee JM, Lee SY, Park TK, Yang JH, Choi JH, Choi SH, Gwon HC, Hahn JY. Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures. JACC Cardiovasc Interv. 2019 Apr 8;12(7):607-620. doi: 10.1016/j.jcin.2019.01.227. Epub 2019 Mar 13.
PubMed 30878474Kobayashi Y, Okura H, Kume T, Yamada R, Kobayashi Y, Fukuhara K, Koyama T, Nezuo S, Neishi Y, Hayashida A, Kawamoto T, Yoshida K. Impact of target lesion coronary calcification on stent expansion. Circ J. 2014;78(9):2209-14. doi: 10.1253/circj.cj-14-0108. Epub 2014 Jul 14.
PubMed 25017740
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07512206
- Acronym / sponsor ID
- AERO CAD / OPCI-AERO-CAD-1.8-Rev D
- Conditions
- Coronary Artery Disease (CAD), Coronary Calcification, Coronary Calcified Disease, Coronary Calcified Nodules
- Keywords
- Aero CAD, Aero IVL, IVL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- OPCI Core Laboratories LLCUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The AERO CAD study is a prospective, multi-center, single-arm, post-market clinical investigation evaluating the procedural performance and clinical outcomes of the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System in patients with calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).
The study will enroll up to 200 subjects across up to 8 U.S. sites. The primary objective is to generate real-world evidence on device performance and clinical outcomes, including target lesion failure at 30 days and procedural success.
Detailed description
The AERO CAD study is designed to characterize real-world clinical performance and outcomes associated with the commercially available Shockwave C2 Aero Coronary IVL catheter.
Coronary artery calcification presents a major challenge during PCI, often leading to suboptimal stent expansion and adverse clinical outcomes. Intravascular lithotripsy (IVL) has emerged as a calcium modification technology that facilitates lesion preparation at low balloon pressures.
The C2 Aero IVL catheter represents a next-generation iteration with improved deliverability, lower profile, enhanced hydrophilic coating, and improved balloon durability. This study evaluates its use in routine clinical practice.
This is a prospective, single-arm, interventional post-market study enrolling patients undergoing PCI with IVL and stenting per standard of care. No additional procedures beyond standard clinical practice are required.
Subjects will be followed through discharge, 30 days, and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - C2 Aero IVL | Other | Device: Shockwave C2 Aero Coronary IVL SystemParticipants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patient undergoing percutaneous coronary intervention (PCI) for coronary artery disease
- Target lesion(s) intended for treatment with intravascular lithotripsy (IVL) and stent implantation per standard of care
- Ability to provide informed consent
- Willingness and ability to comply with study follow-up requirements
Key exclusion criteria (8 listed)
- ST-elevation myocardial infarction (STEMI) at presentation
- Cardiogenic shock at time of procedure
- In-stent restenosis (ISR) target lesion
- Known contraindication to antiplatelet or anticoagulation therapy
- Known intolerance or contraindication to contrast media not amenable to premedication
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 C2 Aero Coronary IVL SystemParticipants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement. | Device | Single Arm - C2 Aero IVL |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 30 days
Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR)
Procedural Success
Time frame: During procedure / during hospitalization (up to 5 days)
Successful delivery of the IVL catheter, delivery of lithotripsy therapy, stent placement with ≤30% residual stenosis, and no in-hospital target lesion failure
7 secondary outcomes
Device Success
Time frame: Index procedure
Serious Angiographic Complications
Time frame: Index procedure
IVL Device Utilization
Time frame: Index procedure
Target Lesion Failure (TLF) at 1 Year
Time frame: 1 year
Individual Components of TLF
Time frame: 30 days and 1 year
Stent Thrombosis
Time frame: 30 days and 1 year
All-Cause Mortality
Time frame: 30 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 39132214Riley RF, Patel MP, Abbott JD, Bangalore S, Brilakis ES, Croce KJ, Doshi D, Kaul P, Kearney KE, Kerrigan JL, McEntegart M, Maehara A, Rymer JA, Sutton NR, Shah B. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions. J Soc Cardiovasc Angiogr Interv. 2024 Jan 31;3(2):101259. doi: 10.1016/j.jscai.2023.101259. eCollection 2024 Feb.
- Background: PubMed 30686041January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons. Circulation. 2019 Jul 9;140(2):e125-e151. doi: 10.1161/CIR.0000000000000665. Epub 2019 Jan 28. No abstract available.
- Background: PubMed 27026020Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available.
- Background: PubMed 28886622Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.
- Background: PubMed 34384555Cho L, Vest AR, O'Donoghue ML, Ogunniyi MO, Sarma AA, Denby KJ, Lau ES, Poole JE, Lindley KJ, Mehran R; Cardiovascular Disease in Women Committee Leadership Council. Increasing Participation of Women in Cardiovascular Trials: JACC Council Perspectives. J Am Coll Cardiol. 2021 Aug 17;78(7):737-751. doi: 10.1016/j.jacc.2021.06.022.
- Background: PubMed 39130137Hussain Y, Kearney KE, Abbott JD, Kereiakes DJ, Di Mario C, Saito S, Cristea E, Riley RF, Fajadet J, Shlofmitz RA, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW, Lansky AJ. Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies. J Soc Cardiovasc Angiogr Interv. 2022 Jan 30;1(1):100011. doi: 10.1016/j.jscai.2021.100011. eCollection 2022 Jan-Feb.
- Background: PubMed 33939604Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.
- Background: PubMed 33551398Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, Nakamura S, Shibata Y; Disrupt CAD IV Investigators. Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study. Circ J. 2021 May 25;85(6):826-833. doi: 10.1253/circj.CJ-20-1174. Epub 2021 Feb 5.
- Background: PubMed 33069849Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.
- Background: PubMed 30715944Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Gotberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531. No abstract available.
- Background: PubMed 31553205Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
- Background: PubMed 34167671Kereiakes DJ, Virmani R, Hokama JY, Illindala U, Mena-Hurtado C, Holden A, Hill JM, Lyden SP, Ali ZA. Principles of Intravascular Lithotripsy for Calcific Plaque Modification. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1275-1292. doi: 10.1016/j.jcin.2021.03.036.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. De-identified data may be made available upon reasonable request and subject to applicable approvals and data use agreements.
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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.
Allen Jeremias, MD, MSc principal investigator
St Francis Hospital & Heart Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave C2 Aero Coronary IVL System in people with Coronary Artery Disease (CAD) and Coronary Calcification, run by OPCI Core Laboratories LLC at 8 sites in United States.
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 8 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: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando A Sosa, MBA (718-753-4862, fernando.sosa@opci.live), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT07512206, which also lists 26 linked publications.
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 6 Apr 2026.