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S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Sirolimus-eluting Coronary Stent System

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ClinicalTrials.gov Identifier: NCT03443999
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Sahajanand Medical Technologies Pvt. Ltd.

Brief Summary:
The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.

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

Detailed Description:

To overcome the potential drawback of the durable polymer a new generation of drug-eluting stent (DES) with a biodegradable polymer has been designed. The first-generation sirolimus-eluting or paclitaxel-eluting stents have a polymer release of antiproliferative drugs from a stainless steel stent platform. More recently, second generation DES have been developed not only to improve long-term DES safety but also to facilitate the procedure by using a cobalt-chromium (Co-Cr) stent platform. Co-Cr is stronger and more radiopaque than stainless steel, and thus allows strut thickness and total stent volume to be reduced while maintaining radial strength leading to a more flexible and deliverable stent platform.

The Sahajanand Medical Technologies Pvt. Ltd. (SMT) has developed sirolimus-eluting stent that contain a biodegradable polymer coating and a Co-Cr stent platform. The purpose of this registry is to evaluate the Supraflex sirolimus-eluting stent in a 'real-world' patient population, in order to determine the safety and efficacy of the stent in wider usage.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prospective Evaluation of the Supraflex Sirolimus-eluting Coronary Stent System in a 'Real-World' Patient Population
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus


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


Primary Outcome Measures :
  1. Target Lesion Failure (TLF) [ Time Frame: 12 months ]
    TLF defined as a composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.


Secondary Outcome Measures :
  1. Target Vessel Failure (TVF) [ Time Frame: 12 months ]
    TVF defined as a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR)

  2. Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]
    MACE defined as a composite endpoint of cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods

  3. Stent Thrombosis [ Time Frame: 12 months ]
    Stent thrombosis rates according to ARC classification

  4. All Deaths [ Time Frame: 12 months ]
    Cardiac death and non-cardiac death (vascular and non-cardiovascular)

  5. Any Myocardial Infarction (MI) [ Time Frame: 12 months ]
    Q wave and non-Q wave MI

  6. Any Repeat Revascularization [ Time Frame: 12 months ]
    Target lesion revascularization (TLR) and target vessel revascularization (TVR)



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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
Real-world patient population assigned for PCI who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Supraflex sirolimus-eluting stent.
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form
  3. Treating physician has electively implanted at least one Supraflex stent as part of the patient's planned clinical care.
  4. The patient is willing and able to cooperate with study procedures and required follow up visits

Exclusion Criteria:

  1. Women with known pregnancy or who are lactating
  2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
  4. Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period

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): NCT03443999


Contacts
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Contact: Vibhor Bhatia +919049528863 vibhor.bhatia@sahmed.com

Locations
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Netherlands
Amphia Ziekenhuis Recruiting
Breda, North Brabant, Netherlands, 4818 CK Breda
Catharina Ziekenhuis Recruiting
Eindhoven, North Brabant, Netherlands, 5623 EJ
Albert Schweitzer Ziekenhuis Recruiting
Dordrecht, South Holland, Netherlands, Post bus 444 3300 AK
Maasstad Ziekenhuis Recruiting
Rotterdam, South Holland, Netherlands, 3079 DZ
Sponsors and Collaborators
Sahajanand Medical Technologies Pvt. Ltd.
Investigators
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Principal Investigator: Dr. A.J.J. IJsselmuiden, MD. Amphia Hospital, Breda, The Netherlands

Additional Information:

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Responsible Party: Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03443999     History of Changes
Other Study ID Numbers: SFLX/Netherlands/001
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
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.:
Coronary Artery Disease
Sirolimus-eluting Stent
Biodegradable Polymers

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
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs