An observational study in Patient Population With Multivessel Disease, sponsored by Sahajanand Medical Technologies Limited. Recruiting at 2 sites in Tunisia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Sahajanand Medical Technologies Limited · Observational
The primary objective of this registry is to evaluate the safety and clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent (SES) in an unselected, all-comer patient population with multivessel disease. This population represents daily clinical practice and includes patients requiring coronary revascularization with drug-eluting stents (DES).
This is a prospective, observational, single-arm, multi-center, registry designed to evaluate the safety and clinical performance of the Supraflex Cruz SES in an unselected, all-comer patient population with multivessel disease. The multivessel disease, defined as the presence of two or more vessels that will be exclusively treated with the Supraflex Cruz SES. The registry aims to reflect daily clinical practice including, but not limited to patients with chronic coronary artery disease (CAD) as well as acute coronary syndrome (STEMI and NSTEMI).
All patients will be followed as per routine clinical practice together with either telephonic or clinical follow-up at 30 days, 6 months, and 12 months after the index procedure.
Subgroups are pre-specified for post-hoc exploratory analyses with respect to the primary endpoint of Target Lesion Failure (TLF) at 12 months. The following subgroups are pre-defined according to their presentation at enrolment:
Sahajanand Medical Technologies Limited is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient population with multivessel disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Supraflex Cruz Sirolimus-eluting Coronary Stent System
Device: Supraflex Cruz Sirolimus-eluting Coronary Stent System
Biodegradable polymer-coated, cobalt-chromium sirolimus-eluting coronary stent
Target Lesion Failure (TLF)
TLF is defined as: "a composite endpoint of cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR)".
Time frame: 12 months
Target Lesion Failure (TLF)
Time frame: 30 days, 6 months
All-cause mortality
Time frame: 30 days, 6 months, and 12 months
Any myocardial infarction (MI), includes non-target vessel territory
Time frame: 30 days, 6 months, and 12 months
Any revascularization
Time frame: 30 days, 6 months, and 12 months
Definite/probable stent thrombosis
Time frame: 30 days, 6 months, and 12 months
Target Vessel Failure (TVF)
TVF is defined as: "a composite endpoint of cardiovascular death, target vessel myocardial infarction, or clinically driven target vessel revascularization"
Time frame: 30 days, 6 months, and 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Nov 2027, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
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Sahajanand Medical Technologies Limited