Novel Compliant Scaffold with Specific Design for Venous System: Results of a Porcine Model Study

Abstract

Background Stenting has become the first-line treatment of obstructive venous disease because of poor results of balloon angioplasty. This preclinical study aimed to investigate the safety and efficacy profile of a novel compliant venous scaffold (CVS) denominated Petalo CVS, specifically designed for venous diseases. Materials and Methods Twelve healthy pigs weighing 90 kg were used to test Petalo CVS. The devices were implanted into the internal jugular veins (IJVs) using a femoral vein percutaneous approach. The safety profile including the success rate of device releasing, anchoring, and positioning was evaluated immediately. Fracture, migration, primary patency, and endothelial response were assessed at 1, 2, 3, and 6 months after the study procedure. Results A total of 32 devices were successfully released in both IJVs. No procedure- or device-related complications were reported, and all pigs successfully completed the different scheduled follow-up periods. The primary patency rate was 100%, and no fracture or migration of the device into the brachiocephalic trunk was reported. Histological examination revealed only minimal lesions with minimal or absent inflammatory reaction surrounding the incorporated metallic rods. Conclusions This porcine model study showed a promising safety and efficacy profile of Petalo CVS, a novel endovenous device based on specific concepts.

A novel endovenous scaffold for the treatment of chronic venous obstruction in a porcine model: Histological and ultrastructural assessment

“…Petalo CVS has a substantially tubular convex shape, including four support modules joined by the transverse bridges. 19 The modules are oriented longitudinally and extended along the entire length of the device’s body. The convexity of the four modules is oriented towards the vein wall.…”

“…The endovascular technique percutaneous approach to venous system and catheter venography was similar to those performed normally in humans, and already described. [17][18][19] Selective venography of the IJVs was performed by manual injection of a low-viscosity contrast medium (Iomeron 150; Bracco Imaging, Milano, Italy) in anterior-posterior projection. After that, at least one device was inserted in the lower or medium segment of the IJV or at site of valve apparatus, by a standard pull back delivery system.…”

“…All data related to the positioning and follow-up of the endovascular device, including the diagnostic procedures and open surgery harvesting of the target vein were recorded on electronic database and hard CRF. 19 All the study procedures were entirely recorded by a video camera. A picture from all surgical specimens was taken and all specimens were classified accordingly.…”

“…At the gross examination, we did not find migration, fracture, thrombosis and/or obstruction of the scaffold, although the clinical results will be detailed in a separate paper. 19 After one to three months by the implant, the central part of the metallic device was free, detached from the intimal surface; conversely, the two extremities of the implant were connected and surrounded by the intimal surface of the vein wall (Figure 2(a)). After six months, the distal region of the device was always enveloped in the intimal surface and in some cases also in the middle region (Figure 3(a)).…”

“…[16][17][18] Quite recently, a compliant nitinol vein scaffold denominated "Petalo CVS," demonstrated intriguing profiles of both safety and efficacy in a porcine model, but histological information about the interaction of the novel stent with the venous wall were completely lacking. 19 Therefore, the purpose of the present pilot study was to evaluate the histologic and ultrastructural aspects of the jugular veins in response to "Petalo CVS" implant in a porcine model.…”