Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment

CCRF

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Procedure: spinous balloon dilatation catheter(lacrosse NSE); Procedure: spinous balloon dilatation catheter (Plastic-Blade)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05342961

KDL-SUF-2021001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd..

Full description

This study is a prospective, multicenter, randomized, controlled and non inferiority designed clinical trial. A total of 160 subjects with CAD from 8 centers will be randomized 1:1 to each group. All subjects evaluated the immediate lumen acquisition immediately after operation and the MACE of 30 ± 7 days after operation. The primary endpoint is the acquisition of lumen immediately after operation. The effectiveness of balloon was evaluated. The safety of balloon was evaluated by adverse events during operation.Clinical follow-up will be conducted at operation, discharge and 30 ± 7 days after operation. The target lesions included the following : opening lesions, bifurcation lesions, calcification lesions and fibrosis lesions; Diameter stenosis ≥ 70% (visual) with evidence of ischemia; Localized lesions with TIMI ≥ 1; RVD=2.00 and 4.00mm , and the vascular segment is suitable for balloon dilatation in anatomical structure。

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. 18-75 years
• 2.Stable or unstable angina, or previous myocardial infarction, or Asymptomatic ischemia judged by clinician ,Target vascular diameter: 2.00-4.00mm ,Coronary artery stenosis stenosis ≥ 70% by visual inspection, or ≥ 50% with evidence of ischemia, TIMI blood flow≥ 1,the operator judge that the patient needs spinous balloon to treat.
• 3. Paticipant can understand the study ,voluntarily participate in and sign the informed consent form,and accept scheduled follow-up.

Exclusion criteria

Patient related:

• 1.Pregnant and breast-feeding women or intention to be pregnant.
• 2.Subjects with MI within one week, or more than one week after the onset of MI,but TNI or TNT have not returned to normal.
• 3.The spinous balloon failed to pass through the stenosis after small balloon dilation , and the lesion need to be rotary grinded.
• 4. Non-target vessel did not be dealed with successful before dealing with target vessel, or non-target vascular lesion number is more than three.
• 5.Serious heart failure（NYHA IV）
• 6.Severe renal failure（Cr>443uMol/L) or patients undergoing hemodialysis.
• 7.Patient with heart transplant.
• 8.Patient with CABG.
• 9.Patients with hemodynamic instability or shock symptoms.
• 10.Life expectancy less than one year.
• 11.Expected to undergo surgery within one month.
• 12.Patients with bleeding tendency, history of active gastrointestinal ulcer, contraindications of antiplatelet or anticoagulant treatment, cannot receive anticoagulant treatment, and patients have hemorrhagic stroke within six months.
• 13.Allergy to heparin and contrast agent.
• 14.The illness of the patient make the treatment and evaluation difficult.
• 15.Those who have participated in other drug or medical device trials have not reached main research endpoint.
• 16.Clinicians estimated that the risk of intervention is very high or the patient should be excluded for other reasons.
• 17.Poor of compliance

Lesion related:

• 18.Lesions of LAD or with a distance of ≤ 2mm beyond LAD.
• 19.Angiogram showed thrombus.
• 20.CTO,and TIMI blood flow=0,
• 21.Coronary artery spasm
• 22.Lesions of LAD without bypass surgery or collateral circulation protection.
• 23.The doctor considered the patient unfit for the trial.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

spinous balloon dilatation catheter(Plastic-Blade)

Experimental group

Description:

Patients with CAD will be treated with spinous balloon dilatation catheter(Plastic-Blade).

Treatment:

Procedure: spinous balloon dilatation catheter (Plastic-Blade)

spinous balloon dilatation catheter(lacrosse NSE)

Experimental group

Description:

Patients with CAD will be treated with spinous balloon dilatation catheter(lacrosse NSE)

Treatment:

Procedure: spinous balloon dilatation catheter(lacrosse NSE)