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Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®

NCT06024525 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2023-09-06

No results posted yet for this study

Summary

The objective of this study is to assess the safety and efficacy of the Paclitaxel-Coated Coronary Balloon Catheters Swide® (3µg/mm2 balloon surface area) in the treatment of Chinese patients with native coronary heart disease and small vessel lesions（reference diameters from 2.0mm to 2.75 mm） in comparison with Paclitaxel-Releasing Coronary Balloon Catheter SeQuent® please Neo

Conditions

Interventions

DEVICE

Paclitaxel-Coated Coronary Balloon Catheters

to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients

DEVICE

Paclitaxel-Releasing Coronary Balloon Catheters

to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients

Sponsors & Collaborators

  • Shanghai Shenqi Medical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-06-01
Completion
2026-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024525 on ClinicalTrials.gov