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

NCT ID: NCT06669195

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2027-03-13

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.

Conditions

Coronary Artery Disease; Calcification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intravascular lithotripsy group

Group Type: EXPERIMENTAL

Intravascular lithotripsy group

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

high-pressure balloon group

Intervention Type: 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.

Interventions

Intravascular lithotripsy group

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.

Intervention Type: DEVICE

high-pressure balloon group

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.

Intervention Type: DEVICE

Eligibility Criteria

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);

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.

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.

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Third People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

yaojun zhang, Ph.D.

Role: CONTACT

mts0207@163.com

0516-85786383

Other Identifiers

2024-02-007-H01

Identifier Type: -

Identifier Source: org_study_id