Status:
UNKNOWN
Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment
Lead Sponsor:
CCRF Inc., Beijing, China
Collaborating Sponsors:
Shanghai 10th People's Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 p...
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 ...
Eligibility Criteria
Inclusion
- 1\. 18-75 years
- 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
- Patient related:
- Pregnant and breast-feeding women or intention to be pregnant.
- 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.
- 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.
- Serious heart failure（NYHA IV）
- Severe renal failure（Cr\>443uMol/L) or patients undergoing hemodialysis.
- Patient with heart transplant.
- Patient with CABG.
- Patients with hemodynamic instability or shock symptoms.
- Life expectancy less than one year.
- Expected to undergo surgery within one month.
- 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.
- Allergy to heparin and contrast agent.
- The illness of the patient make the treatment and evaluation difficult.
- Those who have participated in other drug or medical device trials have not reached main research endpoint.
- Clinicians estimated that the risk of intervention is very high or the patient should be excluded for other reasons.
- Poor of compliance
- Lesion related:
- Lesions of LAD or with a distance of ≤ 2mm beyond LAD.
- Angiogram showed thrombus.
- CTO,and TIMI blood flow=0,
- Coronary artery spasm
- Lesions of LAD without bypass surgery or collateral circulation protection.
- The doctor considered the patient unfit for the trial.
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05342961
Start Date
May 16 2022
End Date
December 31 2022
Last Update
April 25 2022
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