Hertz contact intravascular lithotripsy for calcified coronary artery disease: the PINNACLE-I trial
- multicentre, prospective PINNACLE-I clinical trial
Authors' conclusion
PINNACLE-I demonstrated the feasibility, safety, and efficacy of the novel HC-IVL to fracture calcified lesions and achieve optimal stent expansion in a broad range of calcium morphologies.
Study context
- Population
- Patients with up to two moderately to severely calcified de novo coronary lesionspatients with 63 lesions, optical coherence tomography substudy in 32 subjects
- Participants
- Sixty patients
- Outcome
- <50% residual stenosis without in-hospital major adverse cardiovascular events (MACE) and the 30-day MACE rate
- Follow-up
- In-hospital; 30 days
Main finding
As reported in the abstract
Primary endpoint achieved
98.3%
30-day major adverse cardiovascular events (MACE) rate
1.7%
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Procedure time | HC-IVL median 59.5 (IQR 40.5–76.0) min |
Procedure time
- Median procedure time: 59.5 min (interquartile range: 40.5-76.0)
Residual stenosis after stent placement
- All patients had residual stenosis <30% after stent placement
Optical coherence tomography substudy: calcium morphology, fractures, fracture depth, stent expansion
- Calcium arcs
- 96-360°
- Calcium fractures achieved, of lesions
- 90.6%
- Mean fracture depth
- 0.81±0.33 mm
- Stent expansion at the minimum stent area site
- 96.7±25.5%
- substudy in 32 subjects
Safety
Cardiovascular deaths, definite or probable stent thromboses, device-related events · up to 6 months
- No cardiovascular deaths, no definite or probable stent thromboses, nor any device-related events
Original publication
Hertz contact intravascular lithotripsy for calcified coronary artery disease: the PINNACLE-I trial. EuroIntervention. Published 16 February 2026. doi:10.4244/eij-d-25-00618
Summarised from the published abstract; every number is checked against it