Using a special balloon catheter to treat small vessel coronary diseases

Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases

This study is testing whether a new drug-coated balloon can treat small vessel coronary disease better than another similar balloon to see which one works best for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Acotec Scientific Co., Ltd (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT04626687 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness and safety of a drug-coated balloon (DCB) developed by Acotec Scientific against another DCB made by CARDIONOVUM GmbH in treating small vessel coronary disease. It is a prospective, multi-center, randomized-controlled trial that will assess angiographic restenosis at 9 months post-procedure as the primary endpoint. Participants will undergo clinical follow-ups at various intervals to monitor their progress and outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with symptomatic coronary artery disease and specific stenosis criteria.

Not a fit: Patients who have had an acute myocardial infarction within the past week or have congestive heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a more effective treatment option for patients with small vessel coronary diseases.

How similar studies have performed: Other studies have shown promising results with drug-coated balloons in similar applications, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 18 to 80 years of age
* Subjects with symptomatic coronary artery disease with stable and unstable angina pectoris or secondary evaluation of stenosis after acute myocardial infarction (MI) and asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia determined by the investigator
* Subjects with single, de novo lesion with stenosis of more than 70% (or more than 50% combined with symptoms of ischemia) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.00 mm and ≤ 2.75 mm, and ≤ 26 mm in length.
* Subject must agree to clinical follow-up at 1, 6, 9, 12 months, and angiographic follow-up at 9 months.
* Subject can understand the study objectives psychologically and linguistically and shows sufficient compliance to the study protocol. Subjects express acceptance of the risks and benefits described in the informed consent form.

Exclusion Criteria:

* AMI within 1 week.
* Subject has congestive heart failure or NYHA IV.
* Subject with LVEF \< 35%.
* Subject has undergone heart transplantation.
* Subject has cardiac arrhythmias, such as high-risk ventricular premature beat and/or ventricular tachycardia.
* Subject suffered stroke, gastrointestinal bleeding or active ulcer within the past 6 months, or with conditions associated with high risk of bleeding.
* Subject with a history of leukopenia (white blood cell count of \< 3×109/L for \>3 days), neutropenia (ANC\<1000/mm3 for \>3 days) or thrombocytopenia (platelet \<100,000/mm3).
* Known renal insufficiency (eGFR\<30 ml/min).
* Subject who is forbidden to use anticoagulation agents or anti-platelet drugs, and tolerate Aspirin or Clopidogrel.
* Life expectancy less than 12 months, or subjects who cannot complete 12-month follow-up.
* Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
* Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
* Subject unsuitable for study according to the investigator due to the investigator due to other reasons related to diseases.
* Angiography exclusions:Target lesion: Total occlusion lesion (TIMI 0), heavy calcified lesion that cannot be successfully dilated, bifurcation lesion (side branch ≥ 2.0 mm in diameter), restenosis lesion, thrombotic lesion, or left main disease;Non-target lesion: More than 2 non-target lesions or non-target lesion cannot be successfully treated.

Where this trial is running

Shanghai

• Shanghai Tongji Hospital, Tongji University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Xuebo Liu, MD — Shanghai Tongji Hospital, Tongji University School of Medicine
• Study coordinator: Xuebo Liu, MD

Conditions Coronary Disease; coronary small vessel diseases; DCB