Clinical trial NCT06669195: Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions
Official title: Feasibility and Safety of Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Calcification
Keywords: Intravascular lithotripsy
stent under-expansion
calcified coronary lesions
Lead sponsor: Xuzhou Third People's Hospital
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

1. subjects at the age between ≥18 and ≤80 years old;
2. patients with symptoms or evidence of myocardial ischaemia;
3. 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

1. 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%;
2. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
3. 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;
4. Patients with severe renal failure(eGFR\<30ml/minute) or such medical history, failure to comply with angiography conditions;
5. Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;
6. Patients who plans to accept selective operation within 1 year;
7. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
8. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.

Primary outcomes:
measure: the thickness of neointima
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: