Status unknownNCT05342961Updated Apr 25, 2022

Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment

An interventional study of spinous balloon dilatation catheter (Plastic-Blade) and spinous balloon dilatation catheter(lacrosse NSE) in Coronary Artery Disease, sponsored by CCRF Inc., Beijing, China. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-25.

Sponsored by CCRF Inc., Beijing, China · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 160
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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..

Read the 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。

Conditions studied

Coronary Artery Disease

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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 160 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

CCRF Inc., Beijing, China is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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.
1. Paticipant can understand the study ,voluntarily participate in and sign the informed consent form,and accept scheduled follow-up.

Exclusion criteria

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.
1. 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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 160 participants (estimated)

Study arms

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)
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)

Interventions

Procedurespinous balloon dilatation catheter (Plastic-Blade)
To treat Coronary artery disease
Procedurespinous balloon dilatation catheter(lacrosse NSE)
To treat Coronary artery disease

What researchers measure

Primary outcomes

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.
Time frame: during the procedure

Secondary outcomes

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
Time frame: during the procedure
Rate of clinical success
Based on device success, no patient occurred composite endpoint (PoCE) during hospitalization
Time frame: 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.
Time frame: 30 days after balloon dilatation
% change of clinically meaningful laboratory tests
Record the change of clinically meaningful laboratory tests
Time frame: 30 days after procedure
Number of adverse events
Adverse events occurred during balloon dilatation, after balloon dilatation to 30 ± 7 days after discharge
Time frame: 30 days
Number of device related composite endpoint
Including TLF, Cardiac Death, TV-MI and ID-TLR
Time frame: 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.
Time frame: 30 days
Total time of device operation performance
Push capacity, passing capacity and withdrawal capacity
Time frame: 30 days

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05342961
Lead sponsor: CCRF Inc., Beijing, China
Collaborators: Shanghai 10th People's Hospital
Responsible party: Sponsor
First posted: Apr 25, 2022
Start date: May 16, 2022 (estimated)
Primary completion: Dec 31, 2022 (estimated)
Completion: Dec 31, 2022 (estimated)
Last update: Apr 25, 2022

Study contacts

Yi Zhang, M.D.

Contact

yizshcn@gmail.com

86-21-66300588

Yawei Xu, MD.,Ph D.

principal investigator · Department of Cardiology, Shanghai Tenth People's Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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