Registry evaluating a new stent for patients with multivessel disease
Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Sahajanand Medical Technologies Limited Industry-sponsored |
| Locations | 2 sites (Sousse and 1 other locations) |
| Trial ID | NCT06663696 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic coronary artery multivessel disease requiring at least two Supraflex Cruz stents.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sousse and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.