Patient Population With Multivessel DiseaseNCT06663696
CRUZ Tunisia-Multivessel Registry
An observational study of Patient Population With Multivessel Disease, run by Sahajanand Medical Technologies Limited at 2 sites in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Patient Population With Multivessel Disease
- What is being tested?
- Supraflex Cruz Sirolimus-eluting Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Nov 2024to May 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient population with multivessel disease
Who may be able to join
- Patient must be at least 18 years of age
- Patients with symptomatic coronary artery multivessel disease requiring the implantation of at least two Supraflex Cruz stents into the coronary vasculature during the index procedure
- 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
- The patient is willing and able to co-operate with study procedures and required follow up visits
Who cannot join
- Women with known pregnancy or who are lactating
- High probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons)
- Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
- Patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia2 sites, 2 recruiting
- Recruiting
Sahloul Hospital
Sousse, 4054
Pr. Neffati Elyes
- Recruiting
Habib Thameur Hospital
Tunis, 1089
Pr. Kraiem Sondess
About this study
Official title: Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease
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).
Read the detailed description
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:
- Treatment in relation to clinical presentation [Acute Coronary Syndrome (ACS)]
- Treatment in relation to specific lesion subsets [Left Main, Chronic Total Occlusion]
- Patients undergoing atherectomy
- Being tested
- Supraflex Cruz Sirolimus-eluting Coronary Stent System
- Keywords
- Multivessel disease, Supraflex Cruz, SES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraflex Cruz Sirolimus-eluting Coronary Stent SystemDevice
Biodegradable polymer-coated, cobalt-chromium sirolimus-eluting coronary stent
| Study group | Role | What they receive |
|---|---|---|
| Patient population with multivessel disease | Supraflex Cruz Sirolimus-eluting Coronary Stent System Receives: Device: Supraflex Cruz Sirolimus-eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)".
Measured: 12 months
Secondary outcomes (6)
Target Lesion Failure (TLF)
Measured: 30 days, 6 months
All-cause mortality
Measured: 30 days, 6 months, and 12 months
Any myocardial infarction (MI), includes non-target vessel territory
Measured: 30 days, 6 months, and 12 months
Any revascularization
Measured: 30 days, 6 months, and 12 months
Definite/probable stent thrombosis
Measured: 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"
Measured: 30 days, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Nov 2024
- Primary completionNov 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Population With Multivessel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sahajanand Medical Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Nadhem HAJLAOUI, Principal investigator, University of Tunis El Manar, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663696
- Sponsor's protocol ID
- CRUZ/TUNISIA-MV/01-2023
- Status last verified
- Apr 2026
- First submitted
- 28 Oct 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06663696
- Acronym / sponsor ID
- CRUZ/TUNISIA-MV/01-2023
- Keywords
- Multivessel disease, Supraflex Cruz, SES
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sahajanand Medical Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- Treatment in relation to clinical presentation [Acute Coronary Syndrome (ACS)]
- Treatment in relation to specific lesion subsets [Left Main, Chronic Total Occlusion]
- Patients undergoing atherectomy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient population with multivessel disease | – | Device: Supraflex Cruz Sirolimus-eluting Coronary Stent SystemSupraflex Cruz Sirolimus-eluting Coronary Stent System |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population with multivessel disease
Key inclusion criteria (4 listed)
- Patient must be at least 18 years of age
- Patients with symptomatic coronary artery multivessel disease requiring the implantation of at least two Supraflex Cruz stents into the coronary vasculature during the index procedure
- 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
- The patient is willing and able to co-operate with study procedures and required follow up visits
Key exclusion criteria (4 listed)
- Women with known pregnancy or who are lactating
- High probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons)
- Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
- Patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraflex Cruz Sirolimus-eluting Coronary Stent SystemBiodegradable polymer-coated, cobalt-chromium sirolimus-eluting coronary stent | Device | Patient population with multivessel disease |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months
TLF is defined as: "a composite endpoint of cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR)".
6 secondary outcomes
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)
Time frame: 30 days, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Patient Population With Multivessel Disease
Active, not recruiting
FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease
Coronary Artery Disease, NSTEMI - Non-ST Segment Elevation MI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Nadhem HAJLAOUI principal investigator
University of Tunis El Manar, Tunisia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Population With Multivessel Disease, run by Sahajanand Medical Technologies Limited at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Nadhem HAJLAOUI (+216 55130873, drnadhemhajlaoui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.