Coronary Non-slip Balloon Catheter in Patients With Coronary Artery Stenosis(CREST)

NCT05606367 | Unknown

• 1 other identifier: NAD-D-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, randomized controlled clinical investigation aiming to evaluate the safety and effectiveness of non-slip balloon catheter for the treatment of patients with coronary artery stenosis.

Conditions

Coronary Artery Stenosis

Keywords

stenosis; coronary artery

Outcome Measures

Primary Outcomes (1)

• Acute Lumen Gain

  Acute lumen gain is defined as the difference in the minimum lumen diameter of the target lesion before and after dilatation with the study balloon catheter (Microport or NSE Coronary Dilatation Catheter) as measured by QCA. (Acute lumen gain = minimum lumen diameter measured after dilatation with the study balloon catheter - minimum lumen diameter measured before dilatation with the study balloon catheter, AG=MLD post - MLD pre)

  Baseline procedure

Secondary Outcomes (3)

• Device success

  Baseline procedure

• Lesion success

  Baseline procedure

• Procedural success

  During hospitalization (up to 7 days after procedure)

Study Arms (2)

Non-slip Balloon Catheter

EXPERIMENTAL

Subjects in experimental arm will be treated with the Non-slip Balloon Catheter manufactured by Shanghai Microport Rhythm Co. Ltd.

Device: Non-slip Balloon Catheter of Shanghai MicroPort Rhythm

NSE Coronary Dilatation Catheter

ACTIVE COMPARATOR

Subjects in control arm will be treated with Lacrosse® NSE manufactured by Goodman Medical Co. Ltd.

Device: NSE Coronary Dilatation Catheter

Interventions

Non-slip Balloon Catheter of Shanghai MicroPort Rhythm DEVICE

The principle of Non-slip Balloon Catheter in dilating stenotic lesions is mechanical extrusion of the vessel through the balloon, resulting in irregular rupture of atheromatous plaque and enlargement of the lumen.

Non-slip Balloon Catheter

NSE Coronary Dilatation Catheter DEVICE

The Lacrosse® NSE is an angioplasty catheter with 3 longitudinal elements attached directly proximal and distal to the balloon that produces 3 endovascular surgical incisions during balloon dilation.

Also known as: Lacrosse NSE

NSE Coronary Dilatation Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged≥18 years.
• Subjects with silent myocardial ischemia, symptomatic angina pectoris, or old myocardial infarction.
• Subjects who can undergo percutaneous coronary intervention (PCI).
• Subjects who are able to understand the purpose of the trial, participate voluntarily and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
• For subjects with single or double lesions, revascularization is required for up to two lesions; at most one non-target lesion can be treated in the same period, and the target lesion can be treated only after the treatment of non-target lesion meets the angiography success criteria and there is no complication. Target and non-target lesions must be located in different major epicardial vessels.
• Target lesion meets criteria for revascularization:
• ≥ 70% and \< 100% diameter stenosis; or
• ≥ 50% and \< 70% diameter stenosis with clinical evidence of ischemia
• Target lesion vessel diameter is between 2.0 mm and 4.0 mm (inclusive), target lesion length ≤ 30 mm.
• Clinically judged to be the lesion that requires or is amenable to pretreatment with the study balloon catheter and that the study balloon catheter can pass after pre-dilatation.

You may not qualify if:

• Subjects who present with AMI recently (within 7 days).
• Subjects who plan to undergo rotational atherectomy, laser coronary atherectomy, cutting balloon during target lesion pretreatment.
• Subjects who are scheduled for PCI or CABG within 1 month of the index procedure.
• Subjects with history of ischemic stroke or transient ischemic attack within 3 months.
• Subjects with bleeding tendency, active gastrointestinal ulcer, history of cerebral hemorrhage or subarachnoid hemorrhage, contraindications to antiplatelet agents and anticoagulant therapy, and inability to receive antithrombotic therapy within 6 months.
• Subjects who are scheduled for additional surgical procedures requiring discontinuation of aspirin, clopidogrel within 6 months of the baseline procedure.
• Subjects with severe heart failure (NYHA III and above) or left ventricular ejection fraction(LVEF) \< 35% (ultrasound or left ventriculography) and/or hemodynamic instability.
• Subjects with unstable arrhythmias, such as high-risk premature ventricular contractions, ventricular tachycardia, high-grade atrioventricular block.
• Subjects who are unable to receive antiplatelet therapy.
• Subjects with hypersensitivity to aspirin, heparin, contrast agent, cobalt-based alloys (including metal elements such as cobalt, chromium, nickel, and tungsten), and polytetrafluoroethylene.
• Subjects with renal insufficiency, serum creatinine greater than 177 μmol/L (2.0 mg/dl) or who are receiving hemodialysis.
• Subjects who have been diagnosed with the terminal state of acute and chronic diseases such as advanced cancer and have a life expectancy of less than 1 year.
• Subjects who have already received or are waiting for organ transplantation.
• Subjects with blood routine test showed platelet count less than 50 × 10\^9/L or more than 700 × 10\^9/L, and/or hemoglobin less than 70 g/L.
• Subjects who have participated in other clinical trials of drugs or medical devices before enrollment but have not been to the primary study endpoint until now.

Sponsors & Collaborators

• Shanghai MicroPort Rhythm MedTech Co., Ltd.: lead

Study Sites (1)

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200125, China

RECRUITING

MeSH Terms

Conditions

Coronary Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Bu, M.D.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Wu, M.D.

CONTACT

0086-021-38954600; TingTing.Wu2@microport.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 4, 2022
• Study Start: January 3, 2023
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

CN (1)