Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Coroflex Blue (BMS) followed by SeQuent Please (DEB)
Coroflex Please (DES)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Upper Silesian Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)
Drug Eluting Stent (DES)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
in-stent binary restenosis
defined as >= 50 % diameter stenosis (% DS)
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis
In-stent and in-segment minimal luminal diameter (MLD)
In-segment percent diameter stenosis (%DS)
In-stent and in-segment late luminal loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01166711
Brief Title
Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)
Arm Type
Experimental
Arm Title
Drug Eluting Stent (DES)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Coroflex Blue (BMS) followed by SeQuent Please (DEB)
Other Intervention Name(s)
Coroflex Blue, Cobalt Chromium stent, BMS, SeQuent Please, Paclitaxel-coated Balloon Catheter, DEB
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Coroflex Please (DES)
Other Intervention Name(s)
Coroflex Please, Paclitaxel-Eluting Stent, DES
Intervention Description
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 Outcome Measure Information:
Title
Major adverse cardiac events (MACE) - target vessel failure (TVF)
Description
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
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Major adverse cardiac events (MACE)
Description
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
Time Frame
1 year
Title
in-stent binary restenosis
Description
defined as >= 50 % diameter stenosis (% DS)
Time Frame
9 months
Title
Angiographic and clinical stent thrombosis
Time Frame
30 days
Title
Angiographic and clinical stent thrombosis
Time Frame
6 months
Title
Angiographic and clinical stent thrombosis
Time Frame
9 months
Title
Angiographic and clinical stent thrombosis
Time Frame
1 year
Title
Angiographic and clinical stent thrombosis
Time Frame
2 years
Title
Angiographic and clinical stent thrombosis
Time Frame
3 years
Title
In-stent and in-segment minimal luminal diameter (MLD)
Time Frame
9 months
Title
In-segment percent diameter stenosis (%DS)
Time Frame
9 months
Title
In-stent and in-segment late luminal loss
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paweł E. Buszman, MD, PhD
Organizational Affiliation
American Heart of Poland, Katowice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Upper Silesian Heart Center
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26224390
Citation
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 Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial. J Interv Cardiol. 2015 Aug;28(4):348-57. doi: 10.1111/joic.12210.
Results Reference
result
Learn more about this trial
Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent
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