Coronary Artery DiseaseNCT04733443

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

A study testing Biolimus and SeQuent® Please Neo in people with Coronary Artery Disease, run by JW Medical Systems Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: Biolimus and SeQuent® Please Neo
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 310 participants
Where: 1 siteChina
Study dates: 17 Dec 2020to 18 Feb 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: 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.

Read the detailed description

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

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:

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.

Conditions: Coronary Artery Disease
Being tested: Biolimus, SeQuent® Please Neo
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BiolimusDevice
140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the Biolimus treatment group
SeQuent® Please NeoDevice
140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the SeQuent® Please Neo treatment group

Study groups in NCT04733443
Study group	Role	What they receive
Biolimus	Experimental	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 Receives: Device: Biolimus
SeQuent® Please Neo	Active comparator	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 Receives: Device: SeQuent® Please Neo

What is being measured

The primary outcome is the main question the study is designed to answer.

The late lumen loss
Segmental late lumen loss of target lesions 9 months after surgery
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 202018 Feb 2025

First posted2 Feb 2021
Study start17 Dec 2020
Primary completion18 Jan 2023
Study completion18 Feb 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 310 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04733443
Sponsor's protocol ID: JW-BA9-ISR-202001
Status last verified: Nov 2023
First submitted: 25 Jan 2021
Last updated: 18 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen Y, Gao L, Qin Q, Zhang J, Jia S, Wu M, He Y, Fu G, Liu J, Chen H, Tong Q, Yu Z, An J, Qiu C, Xu B, Cao Y, Wang C, Ma G. Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial. EuroIntervention. 2024 Jul 1;20(13):e806-e817. doi: 10.4244/EIJ-D-24-00295.
PubMed 38742581

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease

All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04733443
Acronym / sponsor ID: JW-BA9-ISR-202001
Conditions: Coronary Artery Disease
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 310 participants (actual)
Lead sponsor: JW Medical Systems LtdIndustry (pharma, biotech, devices)
Study start: 17 Dec 2020 (actual)
Primary completion: 18 Jan 2023 (actual)
Study completion: 18 Feb 2025 (estimated)
First posted: 2 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

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:

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:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Biolimus	Experimental	Device: BiolimusBA9 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
SeQuent® Please Neo	Active comparator	Device: SeQuent® Please Neopaclitaxel 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

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (13 listed)

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%;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biolimus140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the Biolimus treatment group	Device	Biolimus
SeQuent® Please Neo140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the SeQuent® Please Neo treatment group	Device	SeQuent® Please Neo

Primary outcome

The late lumen loss
Time frame: 9 months
Segmental late lumen loss of target lesions 9 months after surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Derived from this study: PubMed 38742581Chen Y, Gao L, Qin Q, Zhang J, Jia S, Wu M, He Y, Fu G, Liu J, Chen H, Tong Q, Yu Z, An J, Qiu C, Xu B, Cao Y, Wang C, Ma G. Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial. EuroIntervention. 2024 Jul 1;20(13):e806-e817. doi: 10.4244/EIJ-D-24-00295.
Individual participant dataSharing planned: No

Related trials for Coronary Artery Disease

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yundai Chen, Ph.D principal investigator

The First Medical Center of the PLA General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biolimus and SeQuent® Please Neo in people with Coronary Artery Disease, run by JW Medical Systems Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The late lumen loss (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04733443, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.