Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02328898
• Other study ID #: 14-244/M
• Status: Recruiting
• Phase: Phase 4
• First received: September 16, 2014
• Last updated: April 23, 2018
• Start date: November 2014
• Est. completion date: September 2020

Study information

• Verified date: April 2018
• Source: UMC Utrecht
• Contact: Pieter R Stella, M.D., PhD
• Phone: +31-88-7556167
• Email: p.stella[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1532
• Est. completion date: September 2020
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Stable
• Stable Angina Pectoris

Intervention

Device:
• Cre8 Stent
Comparison of the Resolute Integrity stent with the Cre8 stent.
• Resolute Integrity stent

Locations

Country	Name	City	State
Luxembourg	Institute of Cardiac Surgery and Interventional Cardiology	Luxembourg
Netherlands	Zuyderland Medical Centre	Heerlen
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Countries where clinical trial is conducted

Luxembourg,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Net Adverse Clinical Events (NACE)	defined as composite of any death, stroke, myocardial infarction, any unplanned repeated revascularization and bleeding (BARC 3a and above)	12 and 36 months
Secondary	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	12 and 36 months
Secondary	Target vessel revascularization by CABG or PCI (TVR)		12 and 36 months
Secondary	Stent thrombosis		12 and 36 months
Secondary	Device, lesion and procedure success at time of baseline procedure		12 and 36 months