Publications by authors named "F J Zidar"
Article Synopsis
- A clinical trial assessed the Cross-Seal vascular closure device's ability to effectively and safely achieve hemostasis in patients using large sheaths (8F-18F) for interventional procedures.
- Conducted on 147 participants, the trial showed a quick average time to hemostasis of just 0.4 minutes, with high technical success (92.3%) and a low rate of major complications (5.7%).
- Results indicate that the Cross-Seal device is a safe and effective option for patients undergoing percutaneous endovascular procedures with large-bore access.
Article Synopsis
- Drug-coated balloons, specifically paclitaxel-coated balloons, show promise for treating coronary in-stent restenosis but previously lacked approval for U.S. use.
- A clinical trial, involving 600 participants across 40 centers, compared the effectiveness of paclitaxel-coated balloons to uncoated ones in preventing target lesion failure one year post-treatment.
- Results indicated that patients receiving the paclitaxel-coated balloon had significantly lower rates of target lesion revascularization and myocardial infarction compared to those with uncoated balloons, demonstrating the coated balloon's superiority (17.9% vs 28.6% failure rate).
Background: While intravascular imaging guidance during percutaneous coronary intervention (PCI) improves outcomes, routine intravascular imaging usage remains low, in part due to perceived inefficiency and safety concerns. Aims: The LightLab (LL) Initiative was designed to evaluate whether implementing a standardised optical coherence tomography (OCT) workflow impacts PCI safety metrics and procedural efficiency.
Methods: In this multicentre, prospective, observational study, PCI procedural data were collected over 2 years from 45 physicians at 17 US centres.
SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent.
Catheter Cardiovasc Interv
June 2017
Importance: Long-term outcomes of an interwoven nitinol stent design represent the best in class for treatment of lower limb arterial obstructive disease METHODS: The subjects were enrolled in an open single arm study comparing the outcomes to an FDA mandated objective performance goal (OPG).
Results: About 325 patients (264 intention-to-treat and 64 roll-in subjects) were enrolled. Mean follow-up period was 887+/- 352 days.
Background: Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance.
Methods And Results: This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery.