Clinical trial NCT04138238: Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent
Official title: Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Sirolimus-eluting Coronary Stent System in the Treatment of All-comer Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Supraflex Cruz
Sirolimus-eluting Stent
High Bleeding Risk
Coronary Artery Disease
Arteriosclerosis
Myocardial Ischemia
Vascular Diseases
Coronary Intervention
Observational Registry
Ultra-thin Strut Biodegradable Polymer
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2019-10-24
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comer patients affected by silent ischemia, stable angina or acute coronary syndrome (unstable angina and non-STEMI), who qualify for percutaneous coronary intervention (PCI), 400 patients of the population must qualify for HBR criteria

Brief summary: This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.


Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 18 years old
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:

1. SYNTAX Score \> 32
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

Primary outcomes:
measure: Device Oriented Composite Endpoint (DOCE)
timeFrame: 12 months
Secondary outcomes:
measure: All death, cardiovascular death and non-cardiovascular death
timeFrame: 6 months and 12 months
measure: All myocardial infarction (MI)
timeFrame: 6 months and 12 months
measure: Target vessel MI and MI not clearly attributable to non-target vessel
timeFrame: 6 months and 12 months
measure: Clinically indicated target lesion revascularization (TLR)
timeFrame: 6 months and 12 months
measure: All target lesion revascularization (TLR)
timeFrame: 6 months and 12 months
measure: All target vessel revascularization (TVR)
timeFrame: 6 months and 12 months
measure: All revascularization
timeFrame: 6 months and 12 months
measure: Stent thrombosis (ARC2)
timeFrame: 6 months and 12 months
measure: Device success
timeFrame: Up to 1 Day
measure: Lesion success
timeFrame: Up to 1 Day
measure: Procedure success
timeFrame: Up to 7 Days
measure: Major bleeding (BARC 3 to 5) in the HBR population
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Haguenau
country: France
facility: Centre Hospitalier Haguenau
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Montpellier
country: France
facility: CHRU de Montpellier
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Toulouse
country: France
facility: CHU de Toulouse - Rangueil
city: Bad Nauheim
country: Germany
facility: Kerckhoff Heart Center
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center Nordrhine Westfalia
city: Bad Segeberg
country: Germany
facility: Segeberg Kliniken
city: Berlin
country: Germany
facility: Charité Campus Mitte
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charité Campus Virchow
city: Dortmund
country: Germany
facility: St Johannes Hospital
city: Dresden
country: Germany
facility: Herzzentrum Dresden - Universitätklinikum an der TU Dresden
city: Dresden
country: Germany
facility: Praxisklinik Dresden
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Essen
country: Germany
facility: Elizabeth Krankenhaus
city: Kiel
country: Germany
facility: UKSH
city: Leipzig
country: Germany
facility: Universität Leipzig - Herzzentrum
city: Neuss
country: Germany
facility: Städtische Kliniken Neuss, Lukaskrankenhaus
city: Regensburg
country: Germany
facility: Universitätsklinikum
city: Wilhelmshaven
country: Germany
facility: Klinikum Wilhelmshaven
city: Fribourg
country: Switzerland
facility: University and Hospital Fribourg
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Klinikum Wilhelmshaven
name: Prof. Christoph K Naber, PD. Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References: