The PerQSeal resorbable vascular patch showed low rates of major vascular complications and rapid hemostasis rates when used for the closure of large bore arteriotomies in the US pivotal PATCH trial. Its manufacturer, Vivasure Medical, will now submit data from the study to the US Food and Drug Administration (FDA) for approval. The single-arm, multi-center, prospective PATCH trial’s results were presented during a Late-Breaking Clinical Trial session on Tuesday at Cardiovascular Research Technologies (CRT) 2025, by Zvonimir Krajcer, MD, an investigator on the study from the Texas Heart Institute, Houston. Access-related complications are an ongoing challenge in large bore percutaneous interventions, researchers on the study noted, citing the CHOICE-CLOSURE trial, which randomized plug and suture-based approaches in 516 transcatheter aortic valve replacement (TAVR) patients with complication rates of 19.4% and 12.0%, respectively. The PerQSeal is a synthetic patch-based vascular closure device (VCD) which seals from inside and fully bio-absorbs in 180 days, used for large hole closure in arteriotomies in various percutaneous interventions. PATCH assessed the safety and effectiveness of the system when used to achieve hemostasis of common femoral arteries using 12 to 22 French sheaths in 149 subjects (21 of whom were roll-in subjects) undergoing percutaneous catheter-based interventional procedures in 19 centers across the US and Europe. Of these procedures, 66% were TAVR, 32% were endovascular aneurysm repair (EVAR) and 2% were other procedure types. The large PerQSeal device was used in 78% of closures and small in 22%. At baseline, the mean age was 76.1 years, mean body mass index was 29.2 kg/m2, 67% were male, and the majority were treated in their left leg (68% left vs 32% right). The mean common femoral artery (CFA) diameter was 9.2 mm, and mean tissue tract depth was 4.8 cm. At discharge, the intent-to-treat (ITT) population was 128 patients, and at 30 days, ITT was 124 subjects. The primary safety endpoint — the rate of major access site complications attributable to the device through 30-days defined by Valve Academic Research Consortium 3 (VARC-3) — occurred in 1.6% of the ITT discharge group and 0.8% of the ITT 30-day population, all due to surgical cut-down for bleeding. Minor device-related complications occurred in 4.8% of the 30-day ITT group (complication rate: 0.016; 97.95% confidence interval [CI]: 0 – 0.06; P = 0.0000012), and 6.3% of the discharge ITT group, due to pseudoaneurysm (3.1% in both), hematoma (0.8% of discharge group), minor bleeding (1.6% of discharge groups vs 0.8% of 30-day group) and stenosis (0.8% in both). The primary efficacy endpoint was the elapsed time in minutes of device removal from the patient to first observed cessation of CFA bleeding. The mean time to hemostasis — measured via angiogram or vascular ultrasound — in 121 patients was 3.78 minutes (97.95% upper CI; P = <0.0001). The median time was 0 minutes (interquartile range: 0 – 5 minutes), with 57% at hemostasis in 0 minutes, 25% in 1 to 5 minutes, 13% in 6 to 10 minutes and 11% in more than 10 minutes. The PATCH results follow the FRONTIER IV and FRONTIER V studies, in which PerQSeal was used to close 181 arteriotomies with 1 major and 10 minor complications. “With the completion of PATCH, the Vivasure PerQSeal VCD has been implanted in over 300 subjects in clinical trials,” the researchers concluded. “These trials demonstrate the robustness of the patch-based VCD, which has a resorbable design that promotes vessel healing and easy reaccess, in closing large bore arterotomies across a myriad of percutaneous interventions. PATCH data will be submitted to the FDA for approval.” Image Credit: Bailey G. Salimes Image Caption: Zvonimir Krajcer, MD, presents during a Late-Breaking Clinical Trial session at Cardiovascular Research Technologies (CRT) 2025 on Tuesday.