2026-07-28
minor
Study Status, Arms and Interventions v19
Re-verified, no change to tracked fields
2026-04-28
notable
Study Status, Study Design, Eligibility, Contacts/Locations v17
Trial status changed: Recruiting → Active, Not Recruiting
Eligibility criteria+6 characters
[...] t be ≥2.5 mm and ≤4.0 mm.
The lesion length must not exceed 3644 mm.
4a) Tandem lesions are allowed and considered one lesio [...] part and as long as the total lesion length does not exceed 3644 mm, except for distal lesions without planned treatment and [...] in ostial location (within 5 mm of the vessel origin) of the LMCA, LAD, LCX, or RI and per the physician's discretion would re [...]
Show 15 earlier versions
2026-03-10
minor
Study Status, Contacts/Locations v15
2026-02-02
minor
Study Status, Contacts/Locations v14
2026-01-07
minor
Study Status, Contacts/Locations v13
2025-12-05
minor
Study Status, Contacts/Locations v12
2025-11-12
minor
Study Status, Eligibility, Contacts/Locations v11
Eligibility criteria+353 characters
[...] procedure.
For subject with stable ischemic heart disease, bloodcardiac 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 [...] cardiac biomarker (troponin) must be less than or equal to 1.5x the URL within 12 hours prior to the index procedure.
6b.
If [...] and as long as the total lesion length does not exceed 36 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; [...] -ST-segment elevation myocardial infarction, NSTEM [...]
2025-10-08
minor
Study Status, Contacts/Locations v10
2025-09-12
minor
Study Status, Contacts/Locations v9
2025-08-28
minor
Study Status, Contacts/Locations v8
2025-07-02
minor
Study Identification, Study Status, Study Description, Eligibility, Contacts/Locations v7
Completion date2027-04→2028-06
Study sites10→12
Eligibility criteria-24 characters
[...] mm of the target lesion.
Target lesion in ostial location (LMCA, LAD, RCA, LCX, or RI, within 5 mm of ostium) or an unprotected LMCA lesion.
Target lesion is a bifurcation with ostial diameter stenos [...]
Study description+6 characters
The CoronaryTECTONIC CAD IVL studyIDE 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 47up to 55 sites in the US.
The clinical outcomes from the Coronary IVL IDE study will be compared to pre-specified performance goals ( [...]
Study title-5 characters
Abbott'sTECTONIC CoronaryCAD IVL IDE Study
2025-06-16
minor
Study Status, Contacts/Locations v6
2025-04-16
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-04→confirmed 2025-04-01
Study sitesdetails revised at 4 of 4 sites
2025-04-04
minor
Study Status, Contacts/Locations v4
2025-04-01
minor
Study Status, Contacts/Locations v3
2025-03-28
minor
Study Status, Contacts/Locations v2
2025-03-25
notable
Withheld→Not Yet Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v1
Trial statusWithheld→Not Yet Recruiting
Primary completion datenot stated→2026-05
Completion datenot stated→2027-04
Start datenot stated→2025-04
Lead sponsor[Redacted]→Abbott Medical Devices
Study title-34 characters
[TrialAbbott's ofCoronary deviceIVL thatIDE is not approved or cleared by the U.S. FDA]Study