Back to resultsRandomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
Primary Purpose
Stable Angina Pectoris, Acute Coronary Syndrome
Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Cre8 Stent
Resolute Integrity stent
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina Pectoris focused on measuring Polymer free stent, percutaneous coronary intervention
Eligibility Criteria
Inclusion Criteria:
General Inclusion Criteria:
- 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
Angiographic Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Institute of Cardiac Surgery and Interventional CardiologyRecruiting
- Zuyderland Medical CentreRecruiting
- UMC UtrechtRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cre8 stent
Resolute Integrity Stent
Arm Description
PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™'
Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™'
Outcomes
Primary Outcome Measures
Target Lesion Failure (TLF)
Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
Secondary Outcome Measures
Net Adverse Clinical Events (NACE)
defined as composite of any death, stroke, myocardial infarction, any unplanned repeated revascularization and bleeding (BARC 3a and above)
Target lesion failure (TLF)
separate components of the primary endpoint; cardiac death, vessel related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
Target vessel revascularization by CABG or PCI (TVR)
Stent thrombosis
Device, lesion and procedure success at time of baseline procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02328898
Brief Title
Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
Official Title
A Prospective, Multi-Center, Open Label, Randomized Controlled, Two Arm Study Evaluating Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent Resolute Integrity Compared to the Polymer Free Amphilimus Eluting Stent Cre8
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
A Prospective, Multi-Center, Open Label, Randomized Controlled, two-arm Study to Evaluate the Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™' Compared to Polymer Free Amphilimus Eluting Stent 'Cre8'. Dual Antiplatelet Therapy duration of 1 Month will be applied in stable angina pectoris patient population. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy (DAPT).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris, Acute Coronary Syndrome
Keywords
Polymer free stent, percutaneous coronary intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1532 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cre8 stent
Arm Type
Experimental
Arm Description
PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™'
Arm Title
Resolute Integrity Stent
Arm Type
Active Comparator
Arm Description
Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™'
Intervention Type
Device
Intervention Name(s)
Cre8 Stent
Other Intervention Name(s)
Resolute Integrity Stent
Intervention Description
Comparison of the Resolute Integrity stent with the Cre8 stent.
Intervention Type
Device
Intervention Name(s)
Resolute Integrity stent
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF)
Description
Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
Time Frame
12 and 36 months
Secondary Outcome Measure Information:
Title
Net Adverse Clinical Events (NACE)
Description
defined as composite of any death, stroke, myocardial infarction, any unplanned repeated revascularization and bleeding (BARC 3a and above)
Time Frame
12 and 36 months
Title
Target lesion failure (TLF)
Description
separate components of the primary endpoint; cardiac death, vessel related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
Time Frame
12 and 36 months
Title
Target vessel revascularization by CABG or PCI (TVR)
Time Frame
12 and 36 months
Title
Stent thrombosis
Time Frame
12 and 36 months
Title
Device, lesion and procedure success at time of baseline procedure
Time Frame
12 and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
General Inclusion Criteria:
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
Angiographic Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pieter R Stella, M.D., PhD
Phone
+31-88-7556167
Email
p.stella@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter R Stella, M.D., PhD
Organizational Affiliation
UMC Utrecht, the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cardiac Surgery and Interventional Cardiology
City
Luxembourg
Country
Luxembourg
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Frambach, MD
Facility Name
Zuyderland Medical Centre
City
Heerlen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mera Stein, MD PhD
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter R Stella, MD, PhD
Phone
+31-88-7556167
Email
p.stella@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Rik Rozemeijer, MD, MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
34794654
Citation
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.
Results Reference
derived
PubMed Identifier
30586704
Citation
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.
Results Reference
derived
Learn more about this trial
Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
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