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STANCE: OCT assessment confirms safety of bioresorbable scaffold in SFA lesions
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A novel stent with a bioresorbable scaffold was found safe in superficial femoral artery lesions, as observed by optical coherence tomography, according to pilot trial results presented at Vascular Interventional Advances 2012.
The STANCE First-in-Human study was a prospective, single-arm, multicenter study that enrolled 25 patients at five sites to assess the safety of a self-expanding bioresorbable scaffold system (Stanza, 480 Biomedical) in the treatment of superficial femoral artery (SFA) lesions.
Overall, technical success was observed in 100% of cases.
A substudy evaluated the feasibility of OCT to visualize and assess procedural success, tissue coverage and bioresorption in the SFA by using OCT to visualize the bioresorbable scaffold in the first eight patients. The researchers reported 644 cross sections, a mean image length of 78 ± 8.5 mm and 574 useable sections (89.1%). The 70 excluded cross sections (10.9%) were excluded for the following reasons:
- Thirty-three for inadequate blood clearance (5.1%), resolved through increasing contrast flow rate and/or total volume;
- Thirty that were out of screen (4.7%), reflecting a limitation of penetration depth;
- Seven as a result of bifurcation (1.1%), which will require a new method for analysis.
During a press conference, trial investigator Andrew Holden, MD, with Auckland University School of Medicine in New Zealand, said the scaffold has been performing very well in terms of maintaining acute lumen in all patients, but longer-term follow-up is necessary.
Also, Holden added, “OCT is certainly feasible. It shows beautiful vessel wall apposition. We’ve seen no fractures. And our early experience at 6 months shows that the scaffolds are getting encapsulated and resorbed.”
For more information:
Holden A. Presented at: Vascular Interventional Advances; Oct. 9-12, 2012; Las Vegas.
Disclosure: Holden reports no relevant financial disclosures.