Clinical trial NCT05342961: Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: CCRF Inc., Beijing, China
Sponsor class: INDUSTRY
Collaborators: name: Shanghai 10th People's Hospital
First posted: 2022-04-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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..

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。

Eligibility criteria: 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.

Primary outcomes:
measure: Immediate lumen acquisition
timeFrame: during the procedure
Secondary outcomes:
measure: Rate of device success
timeFrame: during the procedure
measure: Rate of clinical success
timeFrame: from procedure to discharge ( to the 7th day after procedure)
measure: Incidence of related complications
timeFrame: 30 days after balloon dilatation
measure: % change of clinically meaningful laboratory tests
timeFrame: 30 days after procedure
measure: Number of adverse events
timeFrame: 30 days
measure: Number of device related composite endpoint
timeFrame: 30 days
measure: Number of patient oriented composite endpoint
timeFrame: 30 days
measure: Total time of device operation performance
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Department of Cardiology, Shanghai Tenth People's Hospital
name: Yawei Xu, MD.,Ph D.
role: PRINCIPAL_INVESTIGATOR
References: