NCT03167424

Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis

Observational Study of Treatment of Bioresorbable Vascular Scaffolds Restenosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Spanish Society of Cardiology · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular Scaffolds (Abbott Vascular) remains a challenge. This study will assess the incidence, predisposing factors, pathophysiology and prognosis of the patient in this setting.

Detailed description

Treatment of patients with ISR remains a challenge. Currently both drug-eluting stents (DES) and drug-coated balloons (DCB) are considered as the strategies of choice in this setting. However, existing data about ISR of BVS are scarce (isolated cases and retrospective series with very few patients) on the incidence, predisposing factors, pathophysiology, treatment, and long-term prognosis of these patients. In this sense, a prospective Spanish registry of patients with ISR of DVB can obtain a very relevant clinical information that allows us to advance in our knowledge about this phenomenon that helps to prevent it and to treat it in the safest and most effective way possible. Clinical events will be adjudicated by an independent Clinical Event Committee.

Conditions

• Coronary In-stnent Restenosis

Interventions

Type	Name	Description
DEVICE	Treatment of restenosis	Treatment of in-stent restenosis

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-01
• Completion: 2021-12-01
• First posted: 2017-05-30
• Last updated: 2017-08-11

Locations

10 sites across 1 country: Spain