Registry evaluating a new stent for patients with multivessel disease
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
Run by Sahajanand Medical Technologies Limited · NCT06663696 · Data updated 2026-11-12
This study is testing a new type of stent to see if it is safe and effective for people with multiple blocked heart arteries who need treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Sahajanand Medical Technologies Limited Industry-sponsored |
| Locations | 2 sites (Sousse and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | November 2027 |
| Study ends | May 2028 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT06663696 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with symptomatic coronary artery multivessel disease requiring at least two Supraflex Cruz stents.
✕Probably not a fit
Patients who are pregnant, lactating, or have a high probability of non-adherence to follow-up requirements may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry aims to assess the safety and clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent in patients with multivessel disease requiring coronary revascularization. It is a prospective, observational, single-arm, multi-center study that includes a diverse patient population reflecting daily clinical practice. Patients will be followed up at 30 days, 6 months, and 12 months post-procedure to evaluate outcomes, particularly focusing on Target Lesion Failure. Subgroups will be analyzed based on clinical presentation and specific lesion characteristics.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of the Supraflex Cruz stent, potentially improving treatment options for patients with multivessel disease.
How similar studies have gone: Other studies evaluating drug-eluting stents have shown promising results, indicating that this approach may be beneficial, although the specific use of the Supraflex Cruz stent in this context is being explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient must be at least 18 years of age 2. 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 3. 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 4. The patient is willing and able to co-operate 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. 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
Where it's running
-
Sahloul Hospital
Sousse, Tunisia Recruiting -
Habib Thameur Hospital
Tunis, Tunisia Recruiting
Study contacts
- Principal investigator: Prof. Nadhem HAJLAOUI — University of Tunis El Manar, Tunisia
- Study coordinator: Prof. Nadhem HAJLAOUI
- Email: drnadhemhajlaoui@gmail.com
- Phone: +216 55130873
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.