NCT01166711

Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent

SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Coroflex Blue (BMS) followed by SeQuent Please (DEB)	* standard techniques will be used * maximal vasodilatation after nitro application * baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap) * 6 French guiding catheter at least * target lesion will be crossed with standard guidewire * direct stenting at the discretion of the investigator * if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted) * full lesion coverage will be ensured (with one or more stents) * only insert assigned stent type * BMS needs to be fully embedded in vessel wall * post-dilation with high pressure is required before treatment with DEB * DEB will be inflated with nominal pressure (balloon equates to vessel diameter) * length of DEB should exceed the BMS by 2-3 mm on each side * if dissection, full length of dissection and optional additional stented area should be treated with additional DEB (to avoid geographic miss)
DEVICE	Coroflex Please (DES)	* standard techniques will be used * maximal vasodilatation after nitro application * baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap) * 6 French guiding catheter at least * target lesion will be crossed with standard guidewire * direct stenting at the discretion of the investigator * if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted) * full lesion coverage will be ensured (with one or more stents) * only insert assigned stent type

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-02-01
• Completion: 2015-07-01
• First posted: 2010-07-21
• Last updated: 2018-01-10

Locations

1 site across 1 country: Poland