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Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04138238
Recruitment Status : Unknown
Verified October 2020 by Sahajanand Medical Technologies Pvt. Ltd..
Recruitment status was:  Active, not recruiting
First Posted : October 24, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Cardiovascular European Research Center (CERC)
Information provided by (Responsible Party):
Sahajanand Medical Technologies Pvt. Ltd.

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Supraflex Cruz Sirolimus-eluting Stent

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Group/Cohort Intervention/treatment
Supraflex Cruz Sirolimus-eluting Stent Device: Supraflex Cruz Sirolimus-eluting Stent
Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care




Primary Outcome Measures :
  1. Device Oriented Composite Endpoint (DOCE) [ Time Frame: 12 months ]
    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)


Secondary Outcome Measures :
  1. All death, cardiovascular death and non-cardiovascular death [ Time Frame: 6 months and 12 months ]
  2. All myocardial infarction (MI) [ Time Frame: 6 months and 12 months ]
  3. Target vessel MI and MI not clearly attributable to non-target vessel [ Time Frame: 6 months and 12 months ]
  4. Clinically indicated target lesion revascularization (TLR) [ Time Frame: 6 months and 12 months ]
  5. All target lesion revascularization (TLR) [ Time Frame: 6 months and 12 months ]
    Clinically and non-clinically indicated target lesion revascularization (TLR)

  6. All target vessel revascularization (TVR) [ Time Frame: 6 months and 12 months ]
    Clinically and non-clinically indicated target vessel revascularization (TVR)

  7. All revascularization [ Time Frame: 6 months and 12 months ]
    Any revascularization, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR

  8. Stent thrombosis (ARC2) [ Time Frame: 6 months and 12 months ]
  9. Device success [ Time Frame: Up to 1 Day ]
    Defined as deployment of the stents without system failure or device-related complication

  10. Lesion success [ Time Frame: Up to 1 Day ]
    Defined as the attainment of < 50% residual stenosis of the target lesions post-PCI

  11. Procedure success [ Time Frame: Up to 7 Days ]
    Defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay

  12. Major bleeding (BARC 3 to 5) in the HBR population [ Time Frame: 6 months and 12 months ]


Information from the National Library of Medicine

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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
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
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

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): NCT04138238


Locations
Show Show 26 study locations
Sponsors and Collaborators
Sahajanand Medical Technologies Pvt. Ltd.
Cardiovascular European Research Center (CERC)
Investigators
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Principal Investigator: Prof. Christoph K Naber, PD. Dr. Med. Klinikum Wilhelmshaven
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Responsible Party: Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT04138238    
Other Study ID Numbers: SMT CT 2019-20/108
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sahajanand Medical Technologies Pvt. Ltd.:
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
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs