Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments coroflex blue (bms) followed by sequent please (deb), coroflex please (des)
Phase phase 3
Sponsor Aesculap AG
Start date August 2010
End date February 2013
Trial size 1000 participants
Trial identifier NCT01166711, SEQUENT 1000

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
coroflex blue (bms) followed by sequent please (deb) Coroflex Blue
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)
(Active Comparator)
coroflex please (des) Coroflex Please
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

Primary Outcomes

Measure
Major adverse cardiac events (MACE) - target vessel failure (TVF)
time frame: 9 months

Secondary Outcomes

Measure
Major adverse cardiac events (MACE)
time frame: 1 year
in-stent binary restenosis
time frame: 9 months
Angiographic and clinical stent thrombosis
time frame: 30 days
Angiographic and clinical stent thrombosis
time frame: 6 months
Angiographic and clinical stent thrombosis
time frame: 9 months
Angiographic and clinical stent thrombosis
time frame: 1 year
Angiographic and clinical stent thrombosis
time frame: 2 years
Angiographic and clinical stent thrombosis
time frame: 3 years
In-stent and in-segment minimal luminal diameter (MLD)
time frame: 9 months
In-segment percent diameter stenosis (%DS)
time frame: 9 months
In-stent and in-segment late luminal loss
time frame: 9 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia - Presence of one or more coronary artery stenosis >50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent - One lesion treated with the study device Exclusion Criteria: - Pregnancy - Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material - Inability to provide informed consent - Currently participating in another trial before reaching the primary endpoint - Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period - Acute or recent myocardial infarction - left ventricular ejection fraction (LVEF) < 30 % - Stroke or transient ischemic attack within 6 months - Stented segment longer than 23 mm - Vessel diameter of less than 2,5 mm - Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion

Additional Information

Official title SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial
Principal investigator Paweł E. Buszman, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Aesculap AG.