NCT01874002

Brief Summary

Patients with stenosis in one or more coronary artery are often treated with a percutaneous coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the vessel open over time. The Combo-Stent is a novel stent for use during percutaneous angioplasty. In short, the Combo stent combines a drug eluting technique and an endothelial cell attracting layer. The drug coating is designed to prevent re-narrowing of the stent. The endothelial cell attracting layer is designed to ensure rapid coverage of the stent struts with vascular wall cells. The REMEDEE REGISTRY evaluates the long-term safety and performance of the Combo stent in routine clinical practice. In total 1000 patients will be registered and followed for five years.

Trial Health

50
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
5 countries

9 active sites

Status
unknown

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, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

June 6, 2013

Last Update Submit

December 29, 2015

Conditions

Coronary Artery Disease

Keywords

StentsStentDrug elutingDrug eluting stentDrug eluting stentsEndothelial progenitor cellEndothelial progenitor cell capturingSirolimusSirolimus elutingPercutaneous Coronary InterventionPCIRegistryRegistriesMulti centerMulti centre

Outcome Measures

Primary Outcomes (1)

  • Adjudicated Target Lesion Failure

    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 nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting).

    1 year post-procedure

Secondary Outcomes (31)

  • Adjudicated Target Lesion Failure

    30 days post-procedure

  • Adjudicated Target Lesion Failure

    180 days post procedure

  • Individual components of target lesion failure (TLF)

    1 year post-procedure

  • Individual components of target lesion failure (TLF)

    30 days post-procedure

  • Individual components of target lesion failure (TLF)

    180 days post-procedure

  • +26 more secondary outcomes

Study Arms (1)

Combo stent

Consecutive patients in whom a treatment with a Combo stent in the setting of routine clinical care is attempted are entered into the registry.

Device: Combo stent

Interventions

Combo stentDEVICE

Percutaneous coronary intervention of patients with an indication for stent treatment with the COMBO stent, a stent with an endothelial progenitor cell attracting coating and abluminal sirolimus matrix. All consecutive patients treated with, or attempted treatment with, a COMBO stent are followed by telephone contact for 5 years.

Also known as: Abluminal Sirolimus Coated Bio-Engineered Stent, Combo Bio-Engineered Sirolimus Eluting Stent, SirolimusECS
Combo stent

Eligibility Criteria

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

The registry population consists of consecutive patients in whom a treatment with a Combo stent in the setting of routine clinical care is attempted.

You may qualify if:

  • Consecutive patients eligible for Combo stent placement by percutaneous coronary intervention are included in the REMEDEE REGISTRY

You may not qualify if:

  • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  • Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
  • A life expectancy of \<1 year
  • Explicit refusal of participation in the registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

Location

Academic Medical Center - University of Amsterdam

Amsterdam, 1105AZ, Netherlands

Location

Ter Gooi Ziekenhuizen

Blaricum, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Radboud UMC

Nijmegen, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

Meixoeiro Hospital

Vigo, Spain

Location

Craigavon Cardiac Centre

Craigavon, United Kingdom

Location

Related Publications (7)

  • Granada JF, Inami S, Aboodi MS, Tellez A, Milewski K, Wallace-Bradley D, Parker S, Rowland S, Nakazawa G, Vorpahl M, Kolodgie FD, Kaluza GL, Leon MB, Virmani R. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abluminal matrix. Circ Cardiovasc Interv. 2010 Jun 1;3(3):257-66. doi: 10.1161/CIRCINTERVENTIONS.109.919936. Epub 2010 May 4.

    PMID: 20442358BACKGROUND

  • Nakazawa G, Granada JF, Alviar CL, Tellez A, Kaluza GL, Guilhermier MY, Parker S, Rowland SM, Kolodgie FD, Leon MB, Virmani R. Anti-CD34 antibodies immobilized on the surface of sirolimus-eluting stents enhance stent endothelialization. JACC Cardiovasc Interv. 2010 Jan;3(1):68-75. doi: 10.1016/j.jcin.2009.09.015.

    PMID: 20129572BACKGROUND

  • Chandrasekhar J, Kok MM, Kalkman DN, Aquino MB, Zocca P, Woudstra P, Beijk MA, Kerkmeijer LS, Sartori S, Baber U, Tijssen JG, Koch KT, Dangas GD, Colombo A, Pocock S, von Birgelen C, Mehran R, de Winter RJ; COMBO Collaborators and BIO-RESORT Investigators. 1-Year Clinical Outcomes of All Comers Treated With 2 Bioresorbable Polymer-Coated Sirolimus-Eluting Stents: Propensity Score-Matched Comparison of the COMBO and Ultrathin-Strut Orsiro Stents. JACC Cardiovasc Interv. 2020 Apr 13;13(7):820-830. doi: 10.1016/j.jcin.2019.11.023.

    PMID: 32273094DERIVED

  • 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

  • Kalkman DN, Kerkmeijer LS, Woudstra P, Menown IBA, Suryapranata H, den Heijer P, Iniguez A, van 't Hof AWJ, Erglis A, Arkenbout KE, Muller P, Koch KT, Tijssen JG, Beijk MAM, de Winter RJ. Three-year clinical outcomes after dual-therapy COMBO stent placement: Insights from the REMEDEE registry. Catheter Cardiovasc Interv. 2019 Sep 1;94(3):342-347. doi: 10.1002/ccd.28047. Epub 2018 Dec 18.

    PMID: 30565371DERIVED

  • Kalkman DN, Woudstra P, Menown IBA, den Heijer P, Van't Hof AW, Erglis A, Suryapranata H, Arkenbout KE, Iniguez A, Muller P, Tijssen JG, Beijk MAM, de Winter RJ. Two-year clinical outcomes of patients treated with the dual-therapy stent in a 1000 patient all-comers registry. Open Heart. 2017 Jul 11;4(2):e000634. doi: 10.1136/openhrt-2017-000634. eCollection 2017.

    PMID: 28761685DERIVED

  • Woudstra P, Kalkman DN, den Heijer P, Menown IB, Erglis A, Suryapranata H, Arkenbout KE, Iniguez A, van 't Hof AW, Muller P, Tijssen JG, de Winter RJ. 1-Year Results of the REMEDEE Registry: Clinical Outcomes After Deployment of the Abluminal Sirolimus-Coated Bioengineered (Combo) Stent in a Multicenter, Prospective All-Comers Registry. JACC Cardiovasc Interv. 2016 Jun 13;9(11):1127-34. doi: 10.1016/j.jcin.2016.02.052. Epub 2016 May 18.

    PMID: 27209254DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Robbert J de Winter, MD, PhD

    Academic Medical Centre - University of Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Clinical Cardiology

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 10, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2019

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

ES(1)LU(1)NL(5)LA(1)GB(1)