Clinical trial NCT03069066: Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)
Official title: Prospective Study of Bioresorbable Vascular Scaffold Treatment With Scoring Balloon Pre-dilatation in Patients With In-stent Restenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary In-stent Restenosis
Keywords: In-stent restenosis
Bioresorbable vascular scaffold
Stent
Drug-eluting stent
Coronary angiography
Scoring balloon
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
Collaborators: name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
name: Abbott Medical Devices
name: Terumo Medical Corporation
First posted: 2017-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 after scoring balloon pre-dilatation.

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. The use of scoring balloon pre-dilatation has not been studied previously in this setting.

This prospective Spanish multicenter study will assess the clinical and angiographic outcome of patients with ISR treated with BVS with scoring balloon pre-dilatation. 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. Scoring balloon pre-dilatation is mandatory. 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.

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 outcomes:
measure: Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up
timeFrame: angiographic follow-up at 6-9 months
measure: Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization)
timeFrame: 1 year of clinical follow-up
Secondary outcomes:
measure: Acute gain
timeFrame: procedure
measure: Minimal lumen diameter
timeFrame: procedure
measure: Percent diameter stenosis
timeFrame: procedure
measure: Restenosis rate
timeFrame: 6-9 months
measure: Percent diameter stenosis
timeFrame: 6-9 months
measure: Late loss
timeFrame: 6-9 months
measure: Net gain
timeFrame: 6-9 months
measure: Loss index
timeFrame: 6-9 months
measure: Combined clinical outcome measure (cardiac death, myocardial infarction, target lesion revascularization)
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Cardiac death
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Total mortality
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Myocardial infarction
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Target vessel revascularization
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Target lesion revascularization
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Stent thrombosis
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Major bleeding
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
measure: Target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization)
timeFrame: 1 year, 2 years, 3 years, 4 years, 5 years
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complexo Universitario Hospitalario de Santiago
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: L´Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: San Cristobal de La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
References:
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