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Trial record 45 of 77 for:    "Heart Disease" | "Cobalt"

Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm) (RETO 320)

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ClinicalTrials.gov Identifier: NCT03737565
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación EPIC

Brief Summary:
This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Optimax stent®

Detailed Description:
This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent in de novo coronary lesions with reference diameter ≥ 3.0 mm and Length ≤ 20 mm.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prospective, Multicenter and Observational Registry for the Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm) (Reto 320 Study)
Actual Study Start Date : February 17, 2019
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Coronary Artery Disease Device: Optimax stent®
Percutaneous coronary intervention with Optimax stent®




Primary Outcome Measures :
  1. Safety. The number of composite events of cardiac. [ Time Frame: 6 and 12 month ]
    The number of composite events of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).

  2. Efficacy: Incidence of clinically driven target lesion revascularization (TLR). [ Time Frame: 6 and 12 month ]
    Incidence of clinically driven target lesion revascularization (TLR).Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.


Secondary Outcome Measures :
  1. All death. [ Time Frame: 6 and 12 month ]
    Systemic embolism, Major bleeding event (BARC ≥ 2).

  2. Cardiac death. [ Time Frame: 6 and 12 month ]
    Cardiac death.

  3. Target Vessel revascularization. [ Time Frame: 6 and 12 month ]
    Target Vessel revascularization.

  4. Target lesion revascularization. [ Time Frame: 6 and 12 month ]
    Target lesion revascularization.

  5. Stent thrombosis (ARC definite/probable). [ Time Frame: 6 and 12 month ]
    Stent thrombosis (ARC definite/probable).

  6. Major bleeding event (BARC type 2-5). [ Time Frame: 6 and 12 month ]
    Major bleeding event (BARC type 2-5).

  7. Stroke. [ Time Frame: 6 and 12 month ]
    Stroke.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm.
Criteria

Inclusion Criteria:

  • Patients with age ≥ 18 years old.
  • Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm.
  • Informed consent signed.

Exclusion Criteria:

  • Refusal of the patient to participate at the study.
  • Treatment of other injuries that do not meet the conditions (3x20).

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): NCT03737565


Contacts
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Contact: Fundación EPIC +34987876135 admin@fundacionepic.org

Locations
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Spain
Hospital de Mérida Not yet recruiting
Mérida, Badajoz, Spain, 06800
Hospital Universitario Vall d`Hebron Recruiting
Barcelona, Spain, 08035
Hospital San Pedro de Alcántara Not yet recruiting
Cáceres, Spain, 10003
Hospital Universitario de León Recruiting
León, Spain, 24080
Hospital Universitari Arnau de Vilanova Not yet recruiting
Lleida, Spain, 25198
Sponsors and Collaborators
Fundación EPIC

Additional Information:

Publications of Results:
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Responsible Party: Fundación EPIC
ClinicalTrials.gov Identifier: NCT03737565     History of Changes
Other Study ID Numbers: RETO 320
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: January 2019
Keywords provided by Fundación EPIC:
Cobalt-chromium
Additional relevant MeSH terms:
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Heart Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Nitric Oxide
Tryptophan
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs