NCT02328898

Brief Summary

The study objective is to assess the safety and efficacy of the Permanent Polymer Zotarolimus-Eluting Stent Resolute Integrity™ to the Polymer Free Amphilimus-Eluting Stent Cre8™ compared in an all-comer patient population. 1 month of dual antiplatelet duration will be applied in stable angina pectoris patients. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,532

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_4

Geographic Reach
2 countries

3 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

First Submitted

Initial submission to the registry

September 16, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

3.8 years

First QC Date

September 16, 2014

Last Update Submit

April 23, 2018

Conditions

Stable Angina PectorisAcute Coronary Syndrome

Keywords

Polymer free stentpercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF)

    Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI

    12 and 36 months

Secondary Outcomes (5)

  • Net Adverse Clinical Events (NACE)

    12 and 36 months

  • Target lesion failure (TLF)

    12 and 36 months

  • Target vessel revascularization by CABG or PCI (TVR)

    12 and 36 months

  • Stent thrombosis

    12 and 36 months

  • Device, lesion and procedure success at time of baseline procedure

    12 and 36 months

Study Arms (2)

Cre8 stent

EXPERIMENTAL

PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™'

Device: Cre8 Stent

Resolute Integrity Stent

ACTIVE COMPARATOR

Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™'

Device: Resolute Integrity stent

Interventions

Cre8 StentDEVICE

Comparison of the Resolute Integrity stent with the Cre8 stent.

Also known as: Resolute Integrity Stent
Cre8 stent
Resolute Integrity stentDEVICE
Resolute Integrity Stent

Eligibility Criteria

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

You may qualify if:

  • All-comer patients aged 18 years and older
  • Patient has been informed of the nature of the trial and agrees to its provisions and has provided either oral during emergency procedure, followed by written informed consent, or written informed consent in case of an elective procedure as approved by the Medical Research Ethics Committee (MREC) of the respective investigational site
  • Patient is eligible, according to heart team decision if applicable, for PCI with implantation of a drug-eluting stent (DES)
  • Patient has clinical evidence of ischemic heart disease, angina pectoris, myocardial infarction, or silent ischemia
  • All de-novo lesions and all restenotic lesions (whether native coronary or bypass graft), not amenable for treatment with drug eluting balloons
  • All lesions types are allowed: calcified lesions (lesion preparation with scoring/cutting and rotational atherectomy are allowed), thrombus, chronic total occlusion (CTO; randomized after successful wire crossing and pre-dilatation), bifurcation lesions, ostial lesions, bypass graft (venous and arterial) lesions and left main.
  • There is no limit for lesion length; overlapping stents are allowed, or number of lesions or diseased vessels.
  • Target vessel size reference (visual estimation) between 2.5 mm and 4.5 mm.

You may not qualify if:

  • Inability to provide informed consent
  • Participation in another study for intracoronary stents that had not reached its primary endpoint
  • Planned surgery within the next 3 months
  • Known intolerance to P2Y12 receptor antagonist that would prevent adherence to DAPT, or intolerance to aspirin, clopidogrel, Ticagrelor, Prasugrel, heparin/bivalirudin, contrast agent (that cannot be adequately premedicated) or component of DES
  • Female of childbearing potential, who are pregnant or are planning to become pregnant
  • Life expectancy of less than 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute of Cardiac Surgery and Interventional Cardiology

Luxembourg, Luxembourg

RECRUITING

Zuyderland Medical Centre

Heerlen, Netherlands

RECRUITING

UMC Utrecht

Utrecht, 3584CM, Netherlands

RECRUITING

Related Publications (3)

  • van Hemert ND, Stella PR, Rozemeijer R, Stein M, Frambach P, Kraaijeveld AO, Rittersma SZ, Meijs TA, Leenders GEH, van der Harst P, Agostoni P, Voskuil M; ReCre8 Study Investigators. High bleeding risk in patients undergoing percutaneous coronary intervention with drug-eluting stent implantation: ReCre8 subanalysis. Am Heart J Plus. 2022 Nov 9;24:100227. doi: 10.1016/j.ahjo.2022.100227. eCollection 2022 Dec.

    PMID: 38560639DERIVED

  • van Hemert ND, Voskuil M, Rozemeijer R, Stein M, Frambach P, Pereira B, Rittersma SZ, Kraaijeveld AO, Leenders GEH, Timmers L, van der Harst P, Agostoni P, Stella PR; ReCre8 Study Investigators. 3-Year Clinical Outcomes After Implantation of Permanent-Polymer Versus Polymer-Free Stent: ReCre8 Landmark Analysis. JACC Cardiovasc Interv. 2021 Nov 22;14(22):2477-2486. doi: 10.1016/j.jcin.2021.08.078.

    PMID: 34794654DERIVED

  • Rozemeijer R, Stein M, Voskuil M, van den Bor R, Frambach P, Pereira B, Koudstaal S, Leenders GE, Timmers L, Rittersma SZ, Kraaijeveld AO, Agostoni P, Roes KC, Doevendans PA, Stella PR; ReCre8 Study Investigators. Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent. Circulation. 2019 Jan 2;139(1):67-77. doi: 10.1161/CIRCULATIONAHA.118.037707.

    PMID: 30586704DERIVED

MeSH Terms

Conditions

Angina, StableAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pieter R Stella, M.D., PhD

    UMC Utrecht, the Netherlands

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter R Stella, M.D., PhD

CONTACT

+31-88-7556167p.stella@umcutrecht.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PhD

Study Record Dates

First Submitted

September 16, 2014

First Posted

December 31, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2018

Study Completion

September 1, 2020

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations

NL(2)LU(1)