AzTrials
AzTrials

Coronary Artery CalcificationTECTONICNCT06885177

TECTONIC CAD IVL IDE Study

A study testing Experimental in people with Coronary Artery Calcification and Coronary Artery Disease, run by Abbott Medical Devices at 40 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Experimental
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
335 participants
Where
40 sitesUnited States
Study dates
1 Apr 2025to Jun 2028
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

  • 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.
Show all 19Show fewer
  • 6a. 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.
  • 6b. 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.
  • 7) 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).
  • 8) 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).
  • Anatomic Inclusion Criteria
  • Anatomic inclusion criteria are applied at the time of cardiac catheterization for PCI by the investigator and are visually assessed by angiography. The anatomic inclusion criteria include the following:
  • 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.
  • Evidence of calcification at the lesion site by, a. Angiography, with fluoroscopic radiopacities noted as severe (radiopacities noted without cardiac motion before contrast injection compromising both sides of the arterial lumen) OR b. IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section.
  • Ability to pass a 0.014" guide wire across the lesion.

Who cannot join

  • 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.
Show all 37Show fewer
  • 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%.
  • Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics.
  • Subject in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia).
  • Subject has uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg).
  • Subject with a life expectancy of less than 1 year.
  • Subject has had interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure.
  • Subject has planned interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure.
  • Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery.
  • Subject has a previous stent in the target vessel implanted within the last year.
  • Planned use of atherectomy, scoring or cutting balloon, ultra-high pressure non-compliant balloon, excimer laser coronary atherectomy (ELCA), drug-coated balloon (DCB) or any investigational device other than the current study device
  • Anatomic Exclusion Criteria
  • Anatomic exclusion criteria are applied at the time of cardiac catheterization for PCI by the investigator and are visually assessed by angiography. The anatomic exclusion criteria include the following:
  • Unprotected LMCA diameter stenosis >30%.
  • Target lesion has a myocardial bridge.
  • Target vessel is excessively tortuous, defined as the presence of 2 or more bends >90 degrees or 3 or more bends >75 degrees.
  • Definite or possible thrombus in the target vessel.
  • Evidence of aneurysm in target vessel within 10 mm of the target lesion.
  • Target lesion in ostial location (within 5 mm of the vessel origin) of the LMCA, LAD, LCX, or RI and per the physician's discretion would require stenting into the LMCA.
  • Target lesion is a bifurcation with the side branch having ostial diameter stenosis ≥50% and is an intervenable target (e.g. ≥2.0mm in diameter).
  • Second lesion with >50% stenosis in the same target vessel as the target lesion, including planned treatment of side branches and distal lesions that are ≥2.0 mm in diameter.
  • Target lesion is located in a native vessel that can only be reached by going through an existing coronary artery bypass graft.
  • Any previous stent within 10 mm of the target lesion.
  • Imaging evidence of a dissection (NHLBI dissection grades D-F) in the target vessel after guide wire passage and/or prior to start of IVL treatment

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Ascension St. John Jane Phillips

    Bartlesville, Oklahoma, 74006

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Baylor Scott & White Heart & Vascular Hospital

    Dallas, Texas, 75226

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • The Cardiac & Vascular Institute Research Foundation, LLC

    Gainesville, Florida, 32605

  • Endeavor Health

    Glenview, Illinois, 60201

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Bryan Heart

    Lincoln, Nebraska, 68506

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville

    Louisville, Kentucky, 40202

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Wellstar Kennestone Regional Medical Center

    Marietta, Georgia, 30060

  • Pinnacle Health System

    Mechanicsburg, Pennsylvania, 17050

  • Mt. Sinai Medical Center

    Miami Beach, Florida, 33140

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Shannon Clinic

    San Angelo, Texas, 76903

  • Kaiser Permanente - San Francisco

    San Francisco, California, 94118

  • HonorHealth

    Scottsdale, Arizona, 85258

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • USF Health South Tampa Center

    Tampa, Florida, 33606

  • AdventHealth Tampa

    Tampa, Florida, 33613

  • Montefiore Medical Center - Moses Division

    The Bronx, New York, 10469

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: TECTONIC CAD Intravascular Lithotripsy (IVL) IDE Study

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

Read the detailed description

The TECTONIC CAD IVL IDE Study is a prospective, single-arm, open-label, multi-center study to evaluate the safety and effectiveness of the Abbott Coronary IVL System to treat severely calcified, stenotic de novo coronary arteries prior to stenting in 335 subjects at up to 55 sites in the US. The clinical outcomes from the study will be compared to pre-specified performance goals (PG) established using medical/scientific literature. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the Abbott Coronary IVL System in the United States.

Being tested
Experimental
Keywords
Lithotripsy, Coronary Artery Calcification, PCI (Percutaneous Coronary Intervention), De Novo Coronary Arteries
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.

  • ExperimentalDevice

    Also called SonicForce Coronary IVL System

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

Study groups in NCT06885177
Study groupRoleWhat they receive
Experimental (Abbott Coronary IVL System)ExperimentalParticipants will receive treatment with Abbott's Coronary IVL System followed by stenting.
Receives: Device: Experimental

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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)

    Measured: 30-days post index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion15 May 2026
  4. Study completionJun 2028 (estimated)

Resources

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
Model description
The study device consists of the IVL Console, a single-use disposable Catheter, and the Integrated Connection Cable with Handpiece.
Masking
None (open label)
Enrolment
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885177
Sponsor's protocol ID
ABT-CIP-10540
Acronym
TECTONIC
Status last verified
Sep 2026
First submitted
11 Mar 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental in people with Coronary Artery Calcification and Coronary Artery Disease, run by Abbott Medical Devices at 40 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 19 inclusion and 37 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint: Procedural success with final mean residual stenosis <50% and without in-hospital TLF. (time frame: Within 48 hour post index procedure or prior to discharge, whichever is earlier.). 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 NCT06885177.

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 8 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in