NCT01166711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

July 20, 2010

Last Update Submit

January 9, 2018

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Major adverse cardiac events (MACE)

    1 year

  • in-stent binary restenosis

    9 months

  • Angiographic and clinical stent thrombosis

    30 days

  • Angiographic and clinical stent thrombosis

    6 months

  • Angiographic and clinical stent thrombosis

    9 months

  • +6 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL
Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB)

Drug Eluting Stent (DES)

ACTIVE COMPARATOR
Device: Coroflex Please (DES)

Interventions

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

Also known as: Coroflex Blue, Cobalt Chromium stent, BMS, SeQuent Please, Paclitaxel-coated Balloon Catheter, DEB
Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)
Coroflex Please (DES)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

Also known as: Coroflex Please, Paclitaxel-Eluting Stent, DES
Drug Eluting Stent (DES)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upper Silesian Heart Center

Katowice, 40-635, Poland

Location

Related Publications (1)

  • 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.

    PMID: 26224390RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Paweł E. Buszman, MD, PhD

    American Heart of Poland, Katowice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 21, 2010

Study Start

August 1, 2010

Primary Completion

February 1, 2013

Study Completion

July 1, 2015

Last Updated

January 10, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)