Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Spinous Balloon Dilatation Catheter (Plastic-BladeTM) in the Treatment of Coronary Artery Disease

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..

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: spinous balloon dilatation catheter (Plastic-Blade); Procedure: spinous balloon dilatation catheter(lacrosse NSE)

Detailed 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。

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Zhang, M.D.; Phone Number: 86-21-66300588; Email: yizshcn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: spinous balloon dilatation catheter(Plastic-Blade); Patients with CAD will be treated with spinous balloon dilatation catheter(Plastic-Blade).	Procedure: spinous balloon dilatation catheter (Plastic-Blade); To treat Coronary artery disease
Experimental: spinous balloon dilatation catheter(lacrosse NSE); Patients with CAD will be treated with spinous balloon dilatation catheter(lacrosse NSE)	Procedure: spinous balloon dilatation catheter(lacrosse NSE); To treat Coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate lumen acquisition	The difference of the minimum diameter of the target lesion before and after balloon dilatation in the test or control group measured by QCA.	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device success	Proportion of patients who meet the success criteria. Success criteria be defined as the residual stenosis of the target lesion is less than 50% after balloon dilatation and the balloon delivery system is successfully withdrawn	during the procedure
Rate of clinical success	Based on device success, no patient occurred composite endpoint (PoCE) during hospitalization	from procedure to discharge ( to the 7th day after procedure)
Incidence of related complications	Including acute occlusion, vasospasm, vascular rupture, branch or collateral occlusion, subacute stent thrombosis, intimal tear, dissection, etc.	30 days after balloon dilatation
% change of clinically meaningful laboratory tests	Record the change of clinically meaningful laboratory tests	30 days after procedure
Number of adverse events	Adverse events occurred during balloon dilatation, after balloon dilatation to 30 ± 7 days after discharge	30 days
Number of device related composite endpoint	Including TLF, Cardiac Death, TV-MI and ID-TLR	30 days
Number of patient oriented composite endpoint	Including all cause death, MI, TLR, TVR, Revascularization of any coronary arteries and thrombus at the lesion.	30 days
Total time of device operation performance	Push capacity, passing capacity and withdrawal capacity	30 days

Collaborators and Investigators

• Sponsor: CCRF Inc., Beijing, China
• Collaborators: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Yawei Xu, MD.,Ph D., Department of Cardiology, Shanghai Tenth People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 16, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: KDL-SUF-2021001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No