Clinical trial NCT01166711: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Major adverse cardiac events (MACE) - target vessel failure (TVF)
timeFrame: 9 months
Secondary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 1 year
measure: in-stent binary restenosis
timeFrame: 9 months
measure: Angiographic and clinical stent thrombosis
timeFrame: 30 days
measure: Angiographic and clinical stent thrombosis
timeFrame: 6 months
measure: Angiographic and clinical stent thrombosis
timeFrame: 9 months
measure: Angiographic and clinical stent thrombosis
timeFrame: 1 year
measure: Angiographic and clinical stent thrombosis
timeFrame: 2 years
measure: Angiographic and clinical stent thrombosis
timeFrame: 3 years
measure: In-stent and in-segment minimal luminal diameter (MLD)
timeFrame: 9 months
measure: In-segment percent diameter stenosis (%DS)
timeFrame: 9 months
measure: In-stent and in-segment late luminal loss
timeFrame: 9 months
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Upper Silesian Heart Center
Study officials:
affiliation: American Heart of Poland, Katowice
name: Paweł E. Buszman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.