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

NCT06024525 | Not Yet Recruiting

• 1 other identifier: DP01-048B
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-segment diameter stenosis in target lesion(%).

  DS% = (1 - minimum luminal diameter within the target lesion segment / reference diameter within the target lesion segment) × 100%.

  9 months

Secondary Outcomes (13)

• Technical success rate

  Immediate postoperative

• Lesion success rate

  Immediate postoperative

• Procedural success rate

  during the hospitalization and no more 7 days

• The proportion of subjects with target lesion failure.

  in month-1, 6, 9, 12 ,24

• The proportion of subjects with patient-related composite endpoints

  in month-1, 6, 9, 12 ,24

Study Arms (2)

Paclitaxel-Coated Coronary Balloon Catheters

EXPERIMENTAL

receiving the treatment with Swide®DCB in small vessel cohort

Device: Paclitaxel-Coated Coronary Balloon Catheters

Paclitaxel-Releasing Coronary Balloon Catheter

ACTIVE COMPARATOR

receiving the treatment with SeQuent® please Neo in small vessel cohort

Device: Paclitaxel-Releasing Coronary Balloon Catheters

Interventions

Paclitaxel-Coated Coronary Balloon Catheters DEVICE

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

Paclitaxel-Coated Coronary Balloon Catheters

Paclitaxel-Releasing Coronary Balloon Catheters DEVICE

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

Paclitaxel-Releasing Coronary Balloon Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Related to the patients:
• Age ≥18 and ≤80 years old；
• Subjects with stable angina, or with unstable angina, or with subacute, old myocardial infarction, or evidence of asymptomatic ischemia；
• Subjects with left ventricular ejection fraction ≥ 30%;
• During the study, women of childbearing age should not become pregnant or plan to become pregnant. Therefore, it is recommended that subjects use adequate contraceptive measures until (including) the end of the follow-up period；
• Subjects should have sufficient compliance and agree to receive follow-ups in month-1, 6, 9 and 12, and follow-up visit in year-2. It is required to perform angiography in 9 month；
• Subjects should volunteer to participate in this study, and sign the written informed consent form, and understand all risks and benefits in the informed consent document.
• Related to the diseases:
• The target lesion is primary, in situ coronary artery lesion, located on 1 or 2 different coronary vessels, and the number of target lesions on each coronary vessel does not exceed 1；
• Reference vessel diameter between 2.0 mm and 2.75 mm；
• Non-target vascular lesions need to be treated with interventional therapy first (must be treated at the same time), after successful treatment, random and target lesions will be treated;
• Preoperative diameter stenosis must be ≥70% or ≥50% with ischemia; (visual inspection)
• Each target lesion can only be treated with one experimental drug balloon;

You may not qualify if:

• Subjects with myocardial infarction within one week, or subjects whose troponin has not returned to normal despite the onset of myocardial infarction for more than one week;
• Subjects with severe congestive heart failure or NYHA IV heart failure;
• Women who are pregnant or breastfeeding;
• Subjects whose life expectancy does not exceed 1 year or who have factors that make clinical follow-up difficult;
• Subjects with stroke within 6 months;
• Subjects who are participating in any other clinical trials and have not reached the primary clinical endpoint;
• Existing or history of severe liver failure, therefore not eligible for angiography;
• Existing or history of severe renal failure (GFR\<30ml/min), therefore not eligible for angiography;
• Heart transplant;
• Cardiogenic shock;
• Coronary artery spasm without significant stenosis;
• Evidence of extensive thrombus in the target vessel before intervention;
• Coronary artery bypass grafting using vein grafts;
• Complete occlusion of the target vessel (TIMI grade 0 blood flow before operation)
• Target vessels are distorted or have calcified lesions that cannot be pre-dilated successfully;

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

Meizhou People's Hospital (Huangtang Hospital, Meizhou Academy of Medical Sciences)

Meizhou, Guangdong, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

chaojun gu

CONTACT

+86-13636491192; chaojun.gu@sqmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The use of a third-party independent CEC and an independent coronary angiography core laboratory to adjudicate each primary and other endpoints helps reduce measurement bias from outcome measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 6, 2023
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

CN (1)