Prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of a drug-eluting balloon catheter, and SeQuent Please for patients with coronary stent restenosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900024635

Enrollment

Unknown

Registered

2019-07-19

Start date

2018-10-01

Completion date

Unknown

Last updated

2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary stent restenosis

Interventions

Experimental group:Drug eluting balloon catheter was used

Control group:SeQuent Please was used

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-80, male or female without pregnancy; 2. Patients with evidence of painless myocardial ischemia, stable or unstable angina pectoris, or old myocardial infarction 3. Restenosis after metal stent, Mehran type I, II or III; 4. Diameter stenosis rate of stent restenosis =70% or =50% (visual measurement) with evidence of ischemia.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breast-feeding, or have family planning within the next year; 2. Previous history of cerebral hemorrhage, active peptic ulcer, or gastrointestinal bleeding within 3 months; 3. Patients with bleeding tendency, contraindications of antiplatelet agents and anticoagulants, who cannot receive anticoagulant therapy; 4. Restenosis that cannot be predilated successfully.

Design outcomes

Primary

Measure	Time frame
Degree of vascular stenosis;TIMI blood flow grading;Internal diameter of catheter;The length of the lesion;Proximal and distal reference vessel diameter (RVD);Minimum lumen diameter (MLD);Defined restenosis;	—

Countries

China

Contacts

Public ContactXi Hu

Shanghai Angiocare Medical Technology Co.,Ltd

xhu@heart-acme.com+86 13817021433

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026