Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions

ConditionsCoronary Artery Disease Calcification

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorXuzhou Third People's Hospital

About this trial

Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery. Coronary artery calcification not only makes stent delivery and expansion more difficult during PCI, but also increases the risk of vessel perforation. In addition, calcified plaque can lead to incomplete stent expansion, which increases the risk of in-stent restenosis and thrombosis. Although the technology and techniques of interventional devices continue to improve, heavily calcified lesions remain an important risk factor for PCI failure.

This study is a prospective, multicenter, randomized study. It is planned to select 40 cases of subjects with calcified plaque can lead to incomplete stent expansion who meet the inclusion/exclusion criteria. They are randomly dividing them into Intravascular lithotripsy treatment group and high-pressure balloon treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, and 12 months after operation. Follow-up with angiography and OCT are conducted at 12 months. The primary endpoint was thickness of neointima at 12 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Radiography inclusion criteria

the angiography identified a severely calcified lesion with acute stent under-expansion, i.e., residual stenosis >20% after stenting and 16-atm dilatation with a post-dilatation balloon;

target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);

target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤30 mm (visual assessment);

Disqualifiers

Radiography exclusion criteria

in-stent lesions;

For the left main disease and bifurcation lesion (branch vessel diameter shall be ≥ 2.5mm);

Target lesions were total occlusive lesions (acute or chronic), long lesions (>30 mm), lesion vessel reference diameters >4.0 mm, and lesion angiomatous dilatation;

Trial design

Design model

Parallel

Treatments tested in this trial

Intravascular lithotripsy group
Device
20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Intravascular lithotripsy group.
high-pressure balloon group
Device
20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of high-pressure balloon group.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Intravascular lithotripsy groupExperimental treatment 1 intervention

Group B: high-pressure balloon groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

the thickness of neointima

Time frame

12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuzhou Third People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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