Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138238
• Other study ID #: SMT CT 2019-20/108
• Status: Completed
• Start date: February 19, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2023
• Source: Sahajanand Medical Technologies Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Supraflex Cruz Sirolimus-eluting Stent
Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care

Locations

Country	Name	City	State
France	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
Germany	Kerckhoff Heart Center	Bad Nauheim
Germany	Heart and Diabetes Center Nordrhine Westfalia	Bad Oeynhausen
Germany	Segeberg Kliniken	Bad Segeberg
Germany	Charité Campus Benjamin Franklin	Berlin
Germany	Charité Campus Mitte	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
Switzerland	University and Hospital Fribourg	Fribourg
Switzerland	Kantonsspital St. Gallen	Saint Gallen
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Sahajanand Medical Technologies Limited	Cardiovascular European Research Center (CERC)

Countries where clinical trial is conducted

France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Oriented Composite Endpoint (DOCE)	DOCE is a composite of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically-driven target lesion revascularization (TLR)	12 months
Secondary	All death, cardiovascular death and non-cardiovascular death		6 months and 12 months
Secondary	All myocardial infarction (MI)		6 months and 12 months
Secondary	Target vessel MI and MI not clearly attributable to non-target vessel		6 months and 12 months
Secondary	Clinically indicated target lesion revascularization (TLR)		6 months and 12 months
Secondary	All target lesion revascularization (TLR)	Clinically and non-clinically indicated target lesion revascularization (TLR)	6 months and 12 months
Secondary	All target vessel revascularization (TVR)	Clinically and non-clinically indicated target vessel revascularization (TVR)	6 months and 12 months
Secondary	All revascularization	Any revascularization, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR	6 months and 12 months
Secondary	Stent thrombosis (ARC2)		6 months and 12 months
Secondary	Device success	Defined as deployment of the stents without system failure or device-related complication	Up to 1 Day
Secondary	Lesion success	Defined as the attainment of < 50% residual stenosis of the target lesions post-PCI	Up to 1 Day
Secondary	Procedure success	Defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay	Up to 7 Days
Secondary	Major bleeding (BARC 3 to 5) in the HBR population		6 months and 12 months