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ClinicalTrials.gov ID

NCT02672878

Lead Sponsor

Spanish Society of CardiologyOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

130Estimated

Last Update Posted

Feb 23, 2017Actual

Start Date

Apr 2014

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2020Estimated

Official Title

Prospective Study of Bioresorbable Vascular Scaffold Treatment in Patients With In-stent Restenosis

Brief Summary

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the treatment of patients suffering from ISR.

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, data on the value of BVS in patients with ISR is scarce. BVS are very effective to inhibit neointimal proliferation and they avoid the need of implanting a new permanent metal layer. Accordingly, currently, there is a major interest to elucidate the potential value of BVS in patients with ISR.

This prospective Spanish multicenter study will assess the clinical and angiographic outcome of patients with ISR treated with BVS. BVS will be implanted in selected patients (fulfilling inclusion and exclusion criteria) presenting with either BMS-ISR or DES-ISR. Care will be paid to ensure device optimization. Angiographic follow-up will be obtained at 6-9 months. A centralized angiographic corelab will be used to provide QCA measurements. Clinical follow-up will be also obtained at 1 year and then yearly. Clinical events will be adjudicated by an independent Clinical Event Committee.

• Coronary In-stent Restenosis

• Bioresorbable vascular scaffold

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

In-stent restenosis with ischemia. Signed Informed Consent IRB approval

INCLUSION CRITERIA:

PATIENT

• Age > 20 and < 85 years of age
• Acceptance of late angiographic evaluation
• Angina or objective evidence of ischemia

LESION

• ISR (>50% diameter stenosis on visual assessment)
• Previous stent location known

EXCLUSION CRITERIA:

PATIENT

• Inclusion in other clinical research protocol
• Allergy to antiplatelet agents
• Women in childbearing age
• Severe associated systemic diseases (including renal or liver failure) or diseases affecting life expectancy
• Recent myocardial infarction
• Time from index stent implantation < 1 month
• Anticipated difficulties for late angiographic evaluation

LESION

• Stent thrombosis or large thrombus within the stent
• Angiographic failure during initial stent implantation or persistence or large dissection.
• Severe tortuosity or calcification or major difficulties during previous stent implantation
• Vessel diameter < 2.25 mm (visual assessment)
• Stenosis outside stent stent edge (edge ISR are eligible)
• Very diffuse ISR (>30 mm in length)

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

Single

Lead Sponsor

Spanish Society of CardiologyOTHER

Collaborators

Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaOTHER

Instituto de Investigación Sanitaria Hospital Universitario de la PrincesaOTHER

Abbott Medical DevicesINDUSTRY

Terumo Medical CorporationINDUSTRY

masotti@clinic.ub.es

aperez@secardiologia.es

rhernandez_antolin@hotmail.com

raulmorenog@hotmail.com

jmoreu@sescam.jccm.es