Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent
NCT ID: NCT04138238
Last Updated: 2023-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1200 participants
OBSERVATIONAL
2020-02-19
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Supraflex Cruz Sirolimus-eluting Stent
Supraflex Cruz Sirolimus-eluting Stent
Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care
Interventions
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Supraflex Cruz Sirolimus-eluting Stent
Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care
Eligibility Criteria
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Inclusion Criteria
2. De novo or re-stenotic significant stenosis in at least one native coronary artery
3. Patients with silent ischemia, stable angina, unstable angina or non-STEMI eligible for PCI (no limitation of the number of treated lesions and vessels, except higher tercile of Syntax score assessed by the site)
4. Target lesions suitable for PCI with Drug-eluting Stent (DES) diameter between 2.00 and 4.50 mm
5. Total lesion length should be from 15 to 120 mm
6. Patient is willing and capable to sign the written informed consent and comply with all requirements of the registry
7. Planned staged procedures are allowed within 3 months using Supraflex Cruz stent only
Exclusion Criteria
2. Hemodynamic instability or cardiogenic shock
3. Known hypersensitivity or contraindication to any component of the study stent or the eluting drug, to media contrast, to dual antiplatelet therapy (DAPT) medication required by current practice
4. Subject is pregnant, nursing or is a woman with child-bearing potential
5. Any co-morbid condition with life expectancy \< 1 year or that may result in protocol non-compliance
6. Patients who are participating in another drug or device investigational study, which has not reached its primary endpoint
7. Patients under judicial protection, tutorship or curatorship
18 Years
ALL
No
Sponsors
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European Cardiovascular Research Center
NETWORK
Sahajanand Medical Technologies Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Christoph K Naber, PD. Dr. Med.
Role: PRINCIPAL_INVESTIGATOR
Klinikum Wilhelmshaven
Locations
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Centre Hospitalier Haguenau
Haguenau, , France
Hôpital Privé Jacques Cartier
Massy, , France
CHRU de Montpellier
Montpellier, , France
Hôpital Privé Claude Galien
Quincy-sous-Sénart, , France
Clinique Saint Hilaire
Rouen, , France
CHU de Toulouse - Rangueil
Toulouse, , France
Kerckhoff Heart Center
Bad Nauheim, , Germany
Heart and Diabetes Center Nordrhine Westfalia
Bad Oeynhausen, , Germany
Segeberg Kliniken
Bad Segeberg, , Germany
Charité Campus Mitte
Berlin, , Germany
Charité Campus Benjamin Franklin
Berlin, , Germany
Charité Campus Virchow
Berlin, , Germany
St Johannes Hospital
Dortmund, , Germany
Herzzentrum Dresden - Universitätklinikum an der TU Dresden
Dresden, , Germany
Praxisklinik Dresden
Dresden, , Germany
HELIOS Klinikum Erfurt
Erfurt, , Germany
University Hospital Erlangen
Erlangen, , Germany
Elizabeth Krankenhaus
Essen, , Germany
UKSH
Kiel, , Germany
Universität Leipzig - Herzzentrum
Leipzig, , Germany
Städtische Kliniken Neuss, Lukaskrankenhaus
Neuss, , Germany
Universitätsklinikum
Regensburg, , Germany
Klinikum Wilhelmshaven
Wilhelmshaven, , Germany
University and Hospital Fribourg
Fribourg, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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Other Identifiers
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SMT CT 2019-20/108
Identifier Type: -
Identifier Source: org_study_id
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