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

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB) Device: Coroflex Please (DES)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Aesculap AG:

Primary Outcome Measures:

Major adverse cardiac events (MACE) - target vessel failure (TVF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
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) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
defined as >= 50 % diameter stenosis (% DS)
Angiographic and clinical stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
In-stent and in-segment minimal luminal diameter (MLD) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
In-segment percent diameter stenosis (%DS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
In-stent and in-segment late luminal loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	August 2010
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)	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) Other Names: Coroflex Blue Cobalt Chromium stent BMS SeQuent Please Paclitaxel-coated Balloon Catheter DEB
Active Comparator: Drug Eluting Stent (DES)	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 Other Names: Coroflex Please Paclitaxel-Eluting Stent DES

Arms

Assigned Interventions

Experimental: Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)

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)

Other Names:

Coroflex Blue
Cobalt Chromium stent
BMS
SeQuent Please
Paclitaxel-coated Balloon Catheter
DEB

Active Comparator: Drug Eluting Stent (DES)

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

Other Names:

Coroflex Please
Paclitaxel-Eluting Stent
DES

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166711

Locations

Poland
Upper Silesian Heart Center
Katowice, Poland, 40-635

Sponsors and Collaborators

Aesculap AG

Investigators

Principal Investigator:

Paweł E. Buszman, MD, PhD

American Heart of Poland, Katowice

More Information

No publications provided

Responsible Party:	Aesculap AG
ClinicalTrials.gov Identifier:	NCT01166711 History of Changes
Other Study ID Numbers:	SEQUENT 1000
Study First Received:	July 20, 2010
Last Updated:	October 15, 2012
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Diethylstilbestrol
Paclitaxel
Estrogens, Non-Steroidal
Estrogens

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013