Clinical trial NCT03167424: Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis
Official title: Observational Study of Treatment of Bioresorbable Vascular Scaffolds Restenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary In-stnent Restenosis
Keywords: In-stent restenosis
Bioresorbable vascular scaffold
Coronary angiography
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
First posted: 2017-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-stent restenosis of bioresorbable vascular scaffold.

Brief 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.

Eligibility criteria: In-stent restenosis of BVS with ischemia. Signed Informed Consent IRB approval.

INCLUSION CRITERIA:

PATIENT

* Age \> 20 and \< 85 years of age
* 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
* Refuse to sign Informed Consent

Primary outcomes:
measure: Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization)
timeFrame: 1 year of clinical follow-yp
Secondary outcomes:
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
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
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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