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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB); Device: Coroflex Please (DES)

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: DEB; Coroflex Blue; Cobalt Chromium stent; BMS; SeQuent Please; Paclitaxel-coated Balloon Catheter
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: DES; Coroflex Please; Paclitaxel-Eluting Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
in-stent binary restenosis	defined as >= 50 % diameter stenosis (% DS)	9 months
Angiographic and clinical stent thrombosis		30 days
Angiographic and clinical stent thrombosis		6 months
Angiographic and clinical stent thrombosis		9 months
Angiographic and clinical stent thrombosis		1 year
Angiographic and clinical stent thrombosis		2 years
Angiographic and clinical stent thrombosis		3 years
In-stent and in-segment minimal luminal diameter (MLD)		9 months
In-segment percent diameter stenosis (%DS)		9 months
In-stent and in-segment late luminal loss		9 months

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Paweł E. Buszman, MD, PhD, American Heart of Poland, Katowice

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 20, 2010
• First Posted (ESTIMATE): July 21, 2010

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Trace Elements; Micronutrients; Paclitaxel; Albumin-Bound Paclitaxel; Chromium
• Other Study ID Numbers: SEQUENT 1000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No