AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease

Part of paid clinical trials in Thousand Oaks, California.

Sponsor
OPCI Core Laboratories LLC
Study ID
NCT07512206
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease (CAD)
  • Coronary Calcification
  • Coronary Calcified Disease
  • Coronary Calcified Nodules

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Shockwave C2 Aero Coronary IVL System — DEVICE
    Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Oct 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm - C2 Aero IVL
    Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.

Primary Outcome Measure

Target Lesion Failure (TLF) [ Time Frame: 30 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Los Robles Regional Medical CenterThousand OaksCalifornia91360
Mane Arabyan
[email protected]
626-755-8946
Dhananjay Chatterjee, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford St. John HospitalDetroitMichigan48236
Renee L Bess, BS, RDCS, RVT, CCRP
[email protected]
313.343.4811
Amir Kaki, MD (PRINCIPAL_INVESTIGATOR)
Jersey Shore University Medical CenterNeptune CityNew Jersey07753
Anne DeToro, RN, BS, CCRC
[email protected]
732-776-3499
Daniel H Kiss, MD (PRINCIPAL_INVESTIGATOR)
The Valley HospitalParamusNew Jersey07652
Sequoia L Young, MS, CIP, CIM
[email protected]
201.389.0194
Raj Tayal, MD (PRINCIPAL_INVESTIGATOR)
St Francis Hospital & Heart CenterRoslynNew York11576
Ziad A Ali, MD DPhil
[email protected]
6464501870
Evan S Shlofmitz, DO (PRINCIPAL_INVESTIGATOR)
Ziad A Ali, MD DPhil (SUB_INVESTIGATOR)
Allen Jeremias, MD, MSc (SUB_INVESTIGATOR)
Richard A Shlofmitz, MD (SUB_INVESTIGATOR)
Good Samaritan University HospitalWest IslipNew York11795
Jeffrey W Moses, MD
[email protected]
6463398983
WellSpan Health, York HospitalYorkPennsylvania17403
Alexandra Harper
[email protected]
717-851-5848
Rhian E Davies, DO, MS (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White Health - The Heart Hospital PlanoPlanoTexas75093
Walter Cerqueira, MS, CCRC
[email protected]
469-814-3393
Chadi Dib, MD (PRINCIPAL_INVESTIGATOR)
Karim Al-Azizi, MD (SUB_INVESTIGATOR)

Find similar trials in Thousand Oaks, CA

By research site
Los Robles Regional Medical Center· Thousand Oaks, CAHenry Ford St. John Hospital· Detroit, MIJersey Shore University Medical Center· Neptune City, NJThe Valley Hospital· Paramus, NJSt Francis Hospital & Heart Center· Roslyn, NYGood Samaritan University Hospital· West Islip, NY

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