NCT02183454

Brief Summary

To collect post marketing surveillance data on patients receiving at least one Combo Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Combo Stent in routine clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

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

Study Start

First participant enrolled

June 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

August 1, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

June 26, 2014

Last Update Submit

July 31, 2017

Conditions

Coronary Artery DiseaseAtherosclerosis

Keywords

intracoronary stentdrug eluting stentsirolimusendothelial progenitor cells

Outcome Measures

Primary Outcomes (1)

  • Adjudicated device-oriented composite target lesion failure (TLF)

    Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting (CABG)) at 12 months post procedure.

    12 months post procedure

Secondary Outcomes (9)

  • Adjudicated TLF

    at index procedure, 30 days, 6 months and 12 months post procedure

  • Each of the components of TLF (Cardiac death, Non-fatal MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR))

    at index procedure, 30 days, 6 months, 12 months

  • Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) as a composite of all Death, any MI and ischemia-driven revascularization (TLR/TVR/non-TVR)

    at index procedure, 30 days, 6 months and 12 months

  • Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)

    at index procedure, 30 days, 6 months and 12 months

  • Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition

    at index procedure, 30 days, 6 months and 12 months post-procedure

  • +4 more secondary outcomes

Interventions

OrbusNeich COMBO stentDEVICE

The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients who undergo PCI with (attempted) placement of at least one Combo Stent as part of routine clinical care are entered into the registry. PCI with a Combo Stent is considered attempted when the operator has passed the Combo Stent across the guiding catheter.

In general, consecutive patients are included in the registry. Patients are only excluded from registration if ANY of the following conditions apply: 1. Undergoing PCI for treatment of stent thrombosis 2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) 3. Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned 4. A life expectancy of \<12 months 5. Explicit refusal of participation in the registry

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Amphia Ziekenhuis

Breda, Netherlands

Location

Related Publications (4)

  • Chandrasekhar J, Sartori S, Aquino MB, Baber U, Hajek P, Atzev B, Hudec M, Ong TK, Mates M, Borisov B, Warda HM, den Heijer P, Wojcik J, Iniguez A, Coufal Z, Khashaba A, Schee A, Munawar M, Gerber RT, Yan BP, Tejedor P, Kala P, Liew HB, Lee M, Kalkman DN, Dangas GD, de Winter RJ, Colombo A, Mehran R; MASCOT investigators (Appendix I). Comparison of One-Year Outcomes in Patients >75 Versus </=75 Years With Coronary Artery Disease Treated With COMBO Stents (From The MASCOT Registry). Am J Cardiol. 2020 Jul 15;127:1-8. doi: 10.1016/j.amjcard.2020.04.014. Epub 2020 Apr 24.

    PMID: 32418717DERIVED

  • Chandrasekhar J, Kerkmeijer LS, Kalkman DN, Sartori S, Aquino MB, Woudstra P, Beijk MA, Tijssen JG, Koch KT, Hajek P, Atzev B, Hudec M, Ong TK, Mates M, Borisov B, Warda HM, den Heijer P, Wojcik J, Iniguez A, Coufal Z, Khashaba A, Munawar M, Gerber RT, Yan BP, Lee M, Baber U, Dangas GD, Colombo A, de Winter RJ, Mehran R; MASCOT and REMEDEE investigators (full list of collaborators shown in the Appendix). Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration. Catheter Cardiovasc Interv. 2021 Apr 1;97(5):797-804. doi: 10.1002/ccd.28853. Epub 2020 Mar 21.

    PMID: 32198837DERIVED

  • Chandrasekhar J, Kalkman DN, Aquino MB, Sartori S, Hajek P, Atzev B, Hudec M, Ong TK, Mates M, Borisov B, Warda HM, den Heijer P, Wojcik J, Iniguez A, Coufal Z, Khashaba A, Schee A, Munawar M, Gerber RT, Yan BP, Tejedor P, Kala P, Liew HB, Lee M, Baber U, Vogel B, Dangas GD, Colombo A, de Winter RJ, Mehran R; MASCOT; REMEDEE investigators (Appendix I in the Supplementary material). 1-year results after PCI with the COMBO stent in all-comers in Asia versus Europe: Geographical insights from the COMBO collaboration. Int J Cardiol. 2020 May 15;307:17-23. doi: 10.1016/j.ijcard.2020.01.045. Epub 2020 Jan 24.

    PMID: 32111358DERIVED

  • Colombo A, Chandrasekhar J, Aquino M, Ong TK, Sartori S, Baber U, Lee M, Iniguez A, Hajek P, Borisov B, Atzev B, Den Heijer P, Coufal Z, Hudec M, Mates M, Snyder C, Moalem K, Morrell D, Elmore F, Rowland S, Mehran R; MASCOT Investigators. Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-Year final clinical outcomes from the MASCOT post-marketing registry. Int J Cardiol. 2019 May 15;283:67-72. doi: 10.1016/j.ijcard.2019.01.053. Epub 2019 Jan 21.

    PMID: 30826192DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Antonio Colombo, MD

    San Raffaele Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

July 8, 2014

Study Start

June 1, 2014

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

August 1, 2017

Record last verified: 2017-04

Locations

NL(1)