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

NCT04733443 | Unknown DMC

• 1 other identifier: JW-BA9-ISR-202001
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• The late lumen loss

  Segmental late lumen loss of target lesions 9 months after surgery

  9 months

Study Arms (2)

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

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

Device: SeQuent® Please Neo

Interventions

Biolimus DEVICE

140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the Biolimus treatment group

Biolimus

SeQuent® Please Neo DEVICE

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

SeQuent® Please Neo

Eligibility Criteria

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

You may qualify if:

• \. 18 years ≤ subject age ≤80 years;
• \. Stable angina pectoris, acute coronary syndrome, old myocardial infarction or proven asymptomatic myocardial ischemia;
• \. 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;
• \. 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.

You may not qualify if:

• \. 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;
• \. Patients with severe congestive heart failure (NYHA IV) or severe valvular heart disease;
• \. Female patients who are planning or are pregnant (or breastfeeding);
• \. Patients with severe renal failure with creatinine \>2.0 mg/dL (177 mol/L);
• \. Left ventricular ejection fraction \<30%;
• \. Coagulation disorders, platelet count \<100×109/ L;
• \. Patients with cardiogenic shock;
• \. Patients with concomitant diseases requiring cytoinhibitor or radiotherapy;
• \. Patients who are known to be allergic to aspirin, clopidogrel, Gracilis, ticagrelor, heparin, contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel, or Ticagrelor;
• \. 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;
• \. Patients with a life expectancy of less than 1 year or with underlying factors of difficult clinical follow-up;
• \. Patients who are participating in any other clinical trial;

Sponsors & Collaborators

• JW Medical Systems Ltd: lead

Study Sites (1)

The First Medical Center of the PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Related Publications (1)

• 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.

  PMID: 38742581 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Yundai Chen, Ph.D

  The First Medical Center of the PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 2, 2021
• Study Start: December 17, 2020
• Primary Completion: January 18, 2023
• Study Completion: February 18, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)