Clinical trial NCT02328898: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stable Angina Pectoris
Acute Coronary Syndrome
Keywords: Polymer free stent
percutaneous coronary intervention
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 1532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria:

1. All-comer patients aged 18 years and older
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

Angiographic Inclusion Criteria:

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:

1. Inability to provide informed consent
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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 and 36 months
Secondary outcomes:
measure: Net Adverse Clinical Events (NACE)
timeFrame: 12 and 36 months
measure: Target lesion failure (TLF)
timeFrame: 12 and 36 months
measure: Target vessel revascularization by CABG or PCI (TVR)
timeFrame: 12 and 36 months
measure: Stent thrombosis
timeFrame: 12 and 36 months
measure: Device, lesion and procedure success at time of baseline procedure
timeFrame: 12 and 36 months
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: Institute of Cardiac Surgery and Interventional Cardiology
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Centre
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht, the Netherlands
name: Pieter R Stella, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.