NCT04470934

SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)

PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,302 (estimated)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC) guidelines and according to the Instructions for Use (IFU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).

Detailed description

The objective of the study is to assess the continued safety and efficacy of SeQuent® SCB for the treatment of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts. Study goals are based on non-inferiority for Drug-Coated Balloon (DCB) compared to Paclitaxel-Coated Balloon (PCB) and Dru-eluting Stents (DES) (historical data) with 80% power. Primary and secondary outcome variables are international accepted parameters in stent-trials, which sufficiently describe the efficacy and safety of the investigated device and allow clinical conclusions. Additional attention will be paid to those patients who received, by observation, a shortened dual antiplatelet therapy (DAPT). The aim of the study is to assess the safety and efficacy of the SeQuent® SCB in the treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4 mm with suitable lesion lengths. There is no limitation of lesion lengths. In case the lesion is longer than 34 mm, more than one stent needs to be used.

Conditions

• Coronary Artery Disease
• Myocardial Ischaemia

Interventions

Type	Name	Description
DEVICE	SeQuent® SCB drug-coated balloon catheter	treatment of coronary artery disease with SeQuent® SCB of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts

Timeline

• Start date: 2021-04-30
• Primary completion: 2026-01-31
• Completion: 2027-03-31
• First posted: 2020-07-14
• Last updated: 2025-01-15

Locations

1 site across 1 country: Germany