Skip to main content
MedPathMedPath Home
Clinical Trials/NCT04626687
NCT04626687
Recruiting
Not Applicable

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

Acotec Scientific Co., Ltd1 site in 1 country230 target enrollmentStarted: April 6, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCoronary Disease

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
230
Locations
1
Primary Endpoint
Angiographic percent diameter stenosis
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.

Detailed Description

This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Angiographic percent diameter stenosis

Time Frame: at 9 months post-procedure

(1-Segmental minimum lumen diameter \[MLD\]/ segmental reference vessel diameter \[RVD\]) ×100%

Secondary Outcomes

  • Late lumen loss(at 9 months post-procedure)
  • Acute success(in the procedure)
  • Diameter stenosis in-device(at 9 months post-procedure)
  • Rate of target lesion failure(within 12 months post-procedure)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 4
The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary BifurcationsAngioplasty
NCT01180517Ralf Degenhardt, PhD64
Not yet recruiting
Not Applicable
Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent StrategyCoronary Artery Disease
NCT04842838Peking University Third Hospital1,000
Unknown
Phase 4
Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary LesionsCoronary Artery Disease
NCT01278186B.Braun Surgical SA190
Completed
Phase 2
The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total OcclusionsCoronary Artery DiseaseChronic Total OcclusionNative Coronary Artery
NCT00670436University of Ulm48
Completed
Phase 4
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral ArteryPeripheral Arterial DiseaseArterial Occlusive DiseasesAtherosclerosisArteriosclerosisCardiovascular DiseasesPeripheral Vascular DiseasesPaclitaxelPlaque, AtheroscleroticCritical Limb Ischemia
NCT02212470Instituto Dante Pazzanese de Cardiologia85