The Safety and Efficacy of Biolimus in the Treatment of Patients With in Stent Restenosis

November 16, 2023 updated by: JW Medical Systems Ltd

A Prospective, Multicenter, Non-inferior, Randomized Controlled Clinical Trial Comparing the Safety and Efficacy of Sequent ® Please Neo With Biolimus-released Coronary Balloon Catheter in the Treatment of Coronary Stent Restenosis

This study consisted of a randomized controlled trial group and a long balloon observation group.

In the randomized control group, 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the test group and the control group in a 1:1 ratio; 30 consecutive subjects will be enrolled in the long balloon observation group, using graceful molimus release coronary balloon catheter with length of 45mm; All 310 subjects were followed up at baseline, surgery, discharge, 1 month after surgery, 6 months after surgery, 9 months after surgery, 1, 2 and 3 years after surgery, and angiography was performed at 9 months after surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study consisted of a randomized controlled trial group and a long balloon observation group.

In the randomized control group, 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the test group and the control group in a 1:1 ratio; 30 consecutive subjects will be enrolled in the long balloon observation group, using graceful molimus release coronary balloon catheter with length of 45mm; All 310 subjects were followed up at baseline, surgery, discharge, 1 month after surgery, 6 months after surgery, 9 months after surgery, 1, 2 and 3 years after surgery, and angiography was performed at 9 months after surgery.

The primary endpoint was late lumen loss at 9 months.

The study will enroll 310 subjects. The sample size determination process is as follows:

Randomized controlled trial group:

A prospective, multicenter, randomized, controlled, non-inferior clinical trial design was used with the primary endpoint of intrasegonal LLL at 9 months postoperatively. Sample size was calculated according to the following assumptions:

1) According to previous clinical studies, the LLL of the segment 9 months after paclitaxel release coronary catheter (Sequent Please) was 0.46±0.48mm[1] and 0.46±0.51mm[2]. 2) In this study, it was estimated that the mean LLL in the lesion segment of the experimental group and the control group 9 months after surgery was 0.46mm, and the standard deviation was 0.50mm. 3) The clinically acceptable non-infertility threshold was 0.195mm. When the significance level of the statistical test was set as one-sided 2.5% and the assurance level was set as 80%, they were randomly divided into groups at a ratio of 1:1. 4) Considering the abscission rate of 25% (at the same time considering the early withdrawal from the group caused by other reasons and the random setting), 280 patients were finally enrolled, including 140 in the experimental group and 140 in the control group.

Long balloon observation group:

Because the maximum length of Sequent ® Please Neo in the control group was 40mm, subjects suitable for 45mm long balloon could not be randomly enrolled in the randomized controlled trial group. Therefore, this observation group was selected with a sample size of 30 cases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chen

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • The First Medical Center of the PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. 18 years ≤ subject age ≤80 years;
  • 2. Stable angina pectoris, acute coronary syndrome, old myocardial infarction or proven asymptomatic myocardial ischemia;
  • 3. Subjects have no contraindications to coronary revascularization (PCI or CABG); -4. Subjects agreed to receive clinical follow-up at discharge, 1 month, 6 months, 9 months, 1 year, 2 years and 3 years after surgery, and angiographic follow-up at 9 months after surgery;
  • 5. Subjects can understand the purpose of the study and have sufficient compliance with the study protocol. And willing to sign the informed consent and accept the risks and benefits stated in the informed consent.

Exclusion Criteria:

  • 1. Patients with any myocardial infarction within 1 week, or patients whose myocardial enzyme CK or CK-MB has not returned to normal although myocardial infarction has occurred for more than 1 week;
  • 2. Patients with severe congestive heart failure (NYHA IV) or severe valvular heart disease;
  • 3. Female patients who are planning or are pregnant (or breastfeeding);
  • 4. Patients with severe renal failure with creatinine >2.0 mg/dL (177 mol/L);
  • 5. Left ventricular ejection fraction <30%;
  • 6. Coagulation disorders, platelet count <100×109/ L;
  • 7. Patients with cardiogenic shock;
  • 8. Patients with concomitant diseases requiring cytoinhibitor or radiotherapy;
  • 9. Patients who are known to be allergic to aspirin, clopidogrel, Gracilis, ticagrelor, heparin, contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel, or Ticagrelor;
  • 10. Patients with bleeding constitution or a history of cerebral hemorrhage, active digestive ulcer, or gastrointestinal bleeding in the past 6 months will be restricted or prohibited to use anticoagulant therapy or anticoagulant drugs;
  • 11. Patients with a life expectancy of less than 1 year or with underlying factors of difficult clinical follow-up;
  • 12. Patients who are participating in any other clinical trial;
  • 13. For other reasons, the researchers considered the patients unsuitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Biolimus
BA9 Drug-eluting Coronary Artery Balloon Catheter Length: 10 / 15 / 20 / 25 / 30 / 35 / 40 /45mm Diameter: 2.0/2.25/2.5/2.75/3.0/3.5/4.0 mm
Device: Biolimus
140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the Biolimus treatment group
Active Comparator: SeQuent® Please Neo
paclitaxel released coronary balloon catheters Length: 10 / 15 / 20 / 25 / 30 / 35 / 40 mm Diameter: 2.0/2.25/2.5/2.75/3.0/3.5/4.0 mm
Device: SeQuent® Please Neo
140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the SeQuent® Please Neo treatment group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The late lumen loss
Time Frame: 9 months
Segmental late lumen loss of target lesions 9 months after surgery
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JW Medical Systems Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yundai Chen, Ph.D, The First Medical Center of the PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JW-BA9-ISR-202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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