Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02328898
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pieter Stella, UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Stable Angina Pectoris Acute Coronary Syndrome Device: Cre8 Stent Device: Resolute Integrity stent Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1532 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Cre8 stent
PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8™'
Device: Cre8 Stent
Comparison of the Resolute Integrity stent with the Cre8 stent.
Other Name: Resolute Integrity Stent

Active Comparator: Resolute Integrity Stent
Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™'
Device: Resolute Integrity stent



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Net Adverse Clinical Events (NACE) [ Time Frame: 12 and 36 months ]
    defined as composite of any death, stroke, myocardial infarction, any unplanned repeated revascularization and bleeding (BARC 3a and above)

  2. Target lesion failure (TLF) [ Time Frame: 12 and 36 months ]
    separate components of the primary endpoint; cardiac death, vessel related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI

  3. Target vessel revascularization by CABG or PCI (TVR) [ Time Frame: 12 and 36 months ]
  4. Stent thrombosis [ Time Frame: 12 and 36 months ]
  5. Device, lesion and procedure success at time of baseline procedure [ Time Frame: 12 and 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328898


Contacts
Layout table for location contacts
Contact: Pieter R Stella, M.D., PhD +31-88-7556167 p.stella@umcutrecht.nl

Locations
Layout table for location information
Luxembourg
Institute of Cardiac Surgery and Interventional Cardiology Recruiting
Luxembourg, Luxembourg
Contact: Peter Frambach, MD         
Netherlands
Zuyderland Medical Centre Recruiting
Heerlen, Netherlands
Contact: Mera Stein, MD PhD         
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584CM
Contact: Pieter R Stella, MD, PhD    +31-88-7556167    p.stella@umcutrecht.nl   
Sub-Investigator: Rik Rozemeijer, MD, MSc         
Sponsors and Collaborators
UMC Utrecht
Investigators
Layout table for investigator information
Principal Investigator: Pieter R Stella, M.D., PhD UMC Utrecht, the Netherlands

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pieter Stella, M.D. PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02328898     History of Changes
Other Study ID Numbers: 14-244/M
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Keywords provided by Pieter Stella, UMC Utrecht:
Polymer free stent
percutaneous coronary intervention

Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms