Stable Angina PectorisPhase 4NCT02328898
Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
A Phase 4 study testing Cre8 Stent and Resolute Integrity stent in people with Stable Angina Pectoris and Acute Coronary Syndrome, run by UMC Utrecht at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina Pectoris, Acute Coronary Syndrome
- What is being tested?
- Cre8 Stent and Resolute Integrity stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,532 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2014to Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites, 2 recruiting
- Recruiting
Zuyderland Medical Centre
Heerlen
Mera Stein, MD PhD
- Recruiting
UMC Utrecht
Utrecht, 3584CM
Pieter R Stella, MD, PhD, +31-88-7556167, p.stella@umcutrecht.nl
Rik Rozemeijer, MD, MSc
Luxembourg1 site, 1 recruiting
- Recruiting
Institute of Cardiac Surgery and Interventional Cardiology
Luxembourg
Peter Frambach, MD
About this study
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
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.
Read the 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.
- Conditions
- Stable Angina Pectoris, Acute Coronary Syndrome
- Being tested
- Cre8 Stent, Resolute Integrity stent
- Keywords
- Polymer free stent, percutaneous coronary intervention
- Medical subject headings
- Angina, Stable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cre8 StentDevice
Also called Resolute Integrity Stent
Comparison of the Resolute Integrity stent with the Cre8 stent.
Resolute Integrity stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Cre8 stent | Experimental | PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™' Receives: Device: Cre8 Stent |
| Resolute Integrity Stent | Active comparator | Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™' Receives: Device: Resolute Integrity stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
Measured: 12 and 36 months
Secondary outcomes (5)
Net Adverse Clinical Events (NACE)
defined as composite of any death, stroke, myocardial infarction, any unplanned repeated revascularization and bleeding (BARC 3a and above)
Measured: 12 and 36 months
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
Measured: 12 and 36 months
Target vessel revascularization by CABG or PCI (TVR)
Measured: 12 and 36 months
Stent thrombosis
Measured: 12 and 36 months
Device, lesion and procedure success at time of baseline procedure
Measured: 12 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionSep 2018 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stable Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieter Stella, UMC Utrecht
- Investigators
- Pieter R Stella, M.D., PhD, Principal investigator, UMC Utrecht, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328898
- Sponsor's protocol ID
- 14-244/M
- Status last verified
- Apr 2018
- First submitted
- 16 Sep 2014
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38560639van 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.
PubMed 34794654Rozemeijer 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.
PubMed 30586704
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02328898
- Acronym / sponsor ID
- 14-244/M
- Conditions
- Stable Angina Pectoris, Acute Coronary Syndrome
- Keywords
- Polymer free stent, percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,532 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cre8 stent | Experimental | Device: Cre8 StentPCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™' |
| Resolute Integrity Stent | Active comparator | Device: Resolute Integrity stentComparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cre8 StentAlso: Resolute Integrity StentComparison of the Resolute Integrity stent with the Cre8 stent. | Device | Cre8 stent |
| Resolute Integrity stent | Device | Resolute Integrity Stent |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 and 36 months
Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
5 secondary outcomes
Net Adverse Clinical Events (NACE)
Time frame: 12 and 36 months
Target lesion failure (TLF)
Time frame: 12 and 36 months
Target vessel revascularization by CABG or PCI (TVR)
Time frame: 12 and 36 months
Stent thrombosis
Time frame: 12 and 36 months
Device, lesion and procedure success at time of baseline procedure
Time frame: 12 and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Derived from this study: PubMed 38560639van 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.
- Derived from this study: PubMed 34794654van 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.
- Derived from this study: PubMed 30586704Rozemeijer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter R Stella, M.D., PhD principal investigator
UMC Utrecht, the Netherlands
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cre8 Stent and Resolute Integrity stent in people with Stable Angina Pectoris and Acute Coronary Syndrome, run by UMC Utrecht at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pieter R Stella, M.D., PhD (+31-88-7556167, p.stella@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 12 and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328898, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018; AzTrials last refreshed its copy on 30 Oct 2026.