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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166711
• Other study ID #: SEQUENT 1000
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: January 9, 2018
• Start date: August 2010
• Est. completion date: July 2015

Study information

• Verified date: January 2018
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: July 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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)
• 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

Locations

Country	Name	City	State
Poland	Upper Silesian Heart Center	Katowice

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Zurakowski A, Buszman PP, Milewski KP, Janas A, Gorycki B, Kondys M, Gasior P, Michalak M, Boxberger M, Peppas A, Granada JF, Buszman PE. Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Corona — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (MACE) - target vessel failure (TVF)	consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population	9 months
Secondary	Major adverse cardiac events (MACE)	defined as the composite of cardiovascular death, stroke, myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR), as well as the individual components of target vessel revascularization (TVR) and Major adverse cardiac events (MACE) and stent thrombosis	1 year
Secondary	in-stent binary restenosis	defined as >= 50 % diameter stenosis (% DS)	9 months
Secondary	Angiographic and clinical stent thrombosis		30 days
Secondary	Angiographic and clinical stent thrombosis		6 months
Secondary	Angiographic and clinical stent thrombosis		9 months
Secondary	Angiographic and clinical stent thrombosis		1 year
Secondary	Angiographic and clinical stent thrombosis		2 years
Secondary	Angiographic and clinical stent thrombosis		3 years
Secondary	In-stent and in-segment minimal luminal diameter (MLD)		9 months
Secondary	In-segment percent diameter stenosis (%DS)		9 months
Secondary	In-stent and in-segment late luminal loss		9 months