Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
NCT ID: NCT02328898
Last Updated: 2018-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1532 participants
INTERVENTIONAL
2014-11-30
2020-09-30
Brief Summary
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Detailed Description
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One thousand five hundred thirty-two (1532) patients (1:1 randomization Cre8 stent: Resolute Integrity™ stent) will be enrolled in the study, with clinical follow-up at 12 months to assess the primary end point.
After a period of 12 months, a clinical registry will be implemented Information will be collected at 3-years post procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cre8 stent
PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™'
Cre8 Stent
Comparison of the Resolute Integrity stent with the Cre8 stent.
Resolute Integrity Stent
Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™'
Resolute Integrity stent
Interventions
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Cre8 Stent
Comparison of the Resolute Integrity stent with the Cre8 stent.
Resolute Integrity stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. Patient is eligible, according to heart team decision if applicable, for PCI with implantation of a drug-eluting stent (DES)
4. Patient has clinical evidence of ischemic heart disease, angina pectoris, myocardial infarction, or silent ischemia
1. All de-novo lesions and all restenotic lesions (whether native coronary or bypass graft), not amenable for treatment with drug eluting balloons
2. 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.
3. There is no limit for lesion length; overlapping stents are allowed, or number of lesions or diseased vessels.
4. Target vessel size reference (visual estimation) between 2.5 mm and 4.5 mm.
Exclusion Criteria
2. Participation in another study for intracoronary stents that had not reached its primary endpoint
3. Planned surgery within the next 3 months
4. 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
5. Female of childbearing potential, who are pregnant or are planning to become pregnant
6. Life expectancy of less than 12 months
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Pieter Stella
M.D. PhD
Principal Investigators
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Pieter R Stella, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht, the Netherlands
Locations
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Institute of Cardiac Surgery and Interventional Cardiology
Luxembourg, , Luxembourg
Zuyderland Medical Centre
Heerlen, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Peter Frambach, MD
Role: primary
Mera Stein, MD PhD
Role: primary
References
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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.
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.
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.
Other Identifiers
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14-244/M
Identifier Type: -
Identifier Source: org_study_id
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