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

Xuzhou Third People's Hospital

Status

Not yet enrolling

Conditions

Coronary Artery Disease

Calcification

Treatments

Device: high-pressure balloon group

Device: Intravascular lithotripsy group

Study type

Interventional

Funder types

Other

Identifiers

NCT06669195

2024-02-007-H01

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Radiography inclusion criteria
1. 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;
2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤30 mm (visual assessment);

General inclusion criteria

subjects at the age between ≥18 and ≤80 years old;
patients with symptoms or evidence of myocardial ischaemia;
subjects are willing to participate in the study, sign informed consent form, and accept clinical and angiography follow-up after PCI.

Exclusion criteria

Radiography exclusion criteria
1. in-stent lesions;
2. For the left main disease and bifurcation lesion (branch vessel diameter shall be ≥ 2.5mm);
3. Target lesions were total occlusive lesions (acute or chronic), long lesions (>30 mm), lesion vessel reference diameters >4.0 mm, and lesion angiomatous dilatation;

General inclusion criteria

Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 35%;
Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
Patients with severe renal failure(eGFR<30ml/minute) or such medical history, failure to comply with angiography conditions;
Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;
Patients who plans to accept selective operation within 1 year;
Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.