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

NCT ID: NCT01166711

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2015-07-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Coroflex Blue (BMS) followed by SeQuent Please (DEB)

Intervention Type: DEVICE

• 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)

Drug Eluting Stent (DES)

Group Type: ACTIVE_COMPARATOR

Coroflex Please (DES)

Intervention Type: DEVICE

• 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

Interventions

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)

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Coroflex Blue; Cobalt Chromium stent; BMS; SeQuent Please; Paclitaxel-coated Balloon Catheter; DEB; Coroflex Please; Paclitaxel-Eluting Stent; DES

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aesculap AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paweł E. Buszman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

American Heart of Poland, Katowice

Locations

Upper Silesian Heart Center

Katowice, , Poland

Countries

Poland

References

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.

Reference Type: RESULT

PMID: 26224390 (View on PubMed)

Other Identifiers

SEQUENT 1000

Identifier Type: -

Identifier Source: org_study_id