TECTONIC CAD IVL IDE Study

NCT06885177 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10540
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 40

Brief Summary

A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites

Conditions

Coronary Artery Calcification; Coronary Artery Disease; Stenotic Coronary Lesion

Keywords

Lithotripsy; Coronary Artery Calcification; PCI (Percutaneous Coronary Intervention); De Novo Coronary Arteries

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint: Procedural success with final mean residual stenosis <50% and without in-hospital TLF.

  The primary effectiveness endpoint is procedural success that is defined as stent delivery with final mean residual stenosis \<50% (core laboratory assessed) and without in-hospital TLF.

  Within 48 hour post index procedure or prior to discharge, whichever is earlier.

• Primary Safety Endpoint: TLF at 30-days post index procedure

  The primary safety endpoint is TLF (Target lesion failure) defined as a composite of Cardiac Death, TV-MI (Target vessel myocardial infarction), which includes peri-procedural myocardial infarction (PPMI) defined by ARC-2 and spontaneous MI defined by the fourth universal definition of MI (UDMI), and CD-TLR (clinically driven target lesion revascularization)

  30-days post index procedure

Study Arms (1)

Experimental (Abbott Coronary IVL System)

EXPERIMENTAL

Participants will receive treatment with Abbott's Coronary IVL System followed by stenting.

Device: Experimental

Interventions

Experimental DEVICE

Participants will receive treatment with Abbott's Coronary IVL System followed by stenting.

Experimental (Abbott Coronary IVL System)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age.
• Subject must sign and date a written informed consent form before any study-specific tests or procedures are performed.
• Subject is able and willing to comply with all protocol requirements.
• Subject has native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI.
• For subject with unstable ischemic heart disease, cardiac biomarker (troponin) must be less than or equal to the upper reference limit (URL) within 12 hours prior to the procedure.
• For subject with stable ischemic heart disease, cardiac biomarker (troponin) must be less than or equal to 1.5 times the URL. Blood for cardiac biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.
• a. If drawn prior to the procedure, cardiac biomarker (troponin) must be less than or equal to 1.5x the URL within 12 hours prior to the index procedure.
• b. If drawn at the time of the procedure from the side port of the sheath prior to any intervention, cardiac biomarker results need to be analyzed and resulted prior to registering the subject into the study.
• \) Left ventricular ejection fraction (LVEF) ≥ 25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for these criteria; may be assessed at time of index procedure).
• \) Lesions in non-target vessels requiring PCI may be treated either: a. \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or b. \>24 hours prior to the study procedure if the procedure was successful and uncomplicated; or c. \>30 days after the study procedure (in 1 or 2 non-target vessels).
• The target lesion must be a single de novo coronary lesion that has not been previously treated with ANY interventional procedure.
• Single de novo target lesion stenosis of protected left main coronary artery (LMCA), or left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with: a. Stenosis of ≥70% and \<100% or b. Stenosis ≥50% and \<70% with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or RFR/iFR \<0.89 (or any other non-hyperemic pressure index), or IVUS or OCT minimum lumen area ≤4.0 mm\^2
• The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm.
• The lesion length must not exceed 44 mm. 4a) Tandem lesions are allowed and considered one lesion if they are \<5 mm apart and as long as the total lesion length does not exceed 44 mm, except for distal lesions without planned treatment and that are in vessels ≤2.0 mm in diameter.
• The target vessel must have TIMI grade 3 flow at baseline; may be assessed after pre-dilatation.

You may not qualify if:

• Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
• Subject is a member of a vulnerable population including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the Primary endpoint. For the purposes of this criterion, "participation" is defined as being registered in another trial.
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. For subjects with childbearing potential, a urine or blood pregnancy test is required within 7 days prior to index procedure to verify that subject is not pregnant. Note: Investigators should instruct female patients of childbearing potential to use safe contraception for 12 months after the procedure (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release). It is acceptable to include subjects having a sterilized regular partner.
• Subject unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months.
• Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.
• Subject experienced an acute MI (either ST-segment elevation myocardial infarction, STEMI or non-ST-segment elevation myocardial infarction, NSTEMI) within 7 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK- MB greater than 1 times the local laboratory's ULN.
• Subject has New York Heart Association (NYHA) class III or IV heart failure.
• Subject has renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis.
• Subject has a history of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit.
• Subject has an active peptic ulcer or upper gastrointestinal bleeding within 6 months.
• Subject has an untreated pre-procedural hemoglobin \<8 g/dL or intention to refuse blood transfusions if one should become necessary.
• Subject has a coagulopathy, including but not limited to platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment).
• Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \>750,000 or other disorders.
• Subject has uncontrolled diabetes defined as a HbA1c ≥10%.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (40)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kaiser Permanente - San Francisco

San Francisco, California, 94118, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

The Cardiac & Vascular Institute Research Foundation, LLC

Gainesville, Florida, 32605, United States

Location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Wellstar Kennestone Regional Medical Center

Marietta, Georgia, 30060, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Endeavor Health

Glenview, Illinois, 60201, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Montefiore Medical Center - Moses Division

The Bronx, New York, 10469, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ascension St. John Jane Phillips

Bartlesville, Oklahoma, 74006, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Pinnacle Health System

Mechanicsburg, Pennsylvania, 17050, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Baylor Scott & White Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Shannon Clinic

San Angelo, Texas, 76903, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study device consists of the IVL Console, a single-use disposable Catheter, and the Integrated Connection Cable with Handpiece.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 20, 2025
• Study Start: April 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (40)