Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment (RIBS VI)

Coronary In-stent Restenosis Clinical Trial

— RIBS VI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02672878
• Other study ID #: RIBS VI
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 5, 2016
• Last updated: February 20, 2017
• Start date: April 2014
• Est. completion date: December 2020

Study information

• Verified date: February 2017
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary In-stent Restenosis

Intervention

Device:
• Bioresorbable vascular scaffold

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d´Hebron	Barcelona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitari de Bellvitge	L´Hospitalet de Llobregat	Barcelona
Spain	Complejo Asistencial de León	León
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario de Canarias	San Cristobal de La Laguna	Santa Cruz de Tenerife
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Complexo Universitario Hospitalario de Santiago	Santiago de Compostela	A Coruña
Spain	Complejo Hospitalario de Toledo	Toledo
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital de Galdakao	Vizcaya

Sponsors (6)

Lead Sponsor	Collaborator
Spanish Society of Cardiology	Abbott Vascular, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Hospital Universitario de La Princesa (IIS-IP), St. Jude Medical, Terumo Medical Corporation

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Alfonso F, Augé JM, Zueco J, Bethencourt A, López-Mínguez JR, Hernández JM, Bullones JA, Calvo I, Esplugas E, Pérez-Vizcayno MJ, Moreno R, Fernández C, Hernández R, Gama-Ribeiro V; RIBS Investigators.. Long-term results (three to five years) of the Resten — View Citation

Alfonso F, Cequier A, Angel J, Martí V, Zueco J, Bethencourt A, Mantilla R, López-Minguez JR, Gómez-Recio M, Morís C, Perez-Vizcayno MJ, Fernández C, Macaya C, Seabra-Gomes R; Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) Inve — View Citation

Alfonso F, Melgares R, Mainar V, Lezaún R, Vázquez N, Tascón J, Pomar F, Cequier A, Angel J, Pérez-Vizcayno MJ, Sabaté M, Bañuelos C, Fernández C, García JM; Restensois Intra-stent: Ballon angioplasty versus elective Stenting (RIBS) Investigators.. Therap — View Citation

Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García del Blanco B, García-Touchard A, López-Minguéz JR, Benedicto A, Masotti M, Zueco J, Iñiguez A, Velázquez M, Moreno R, Mainar V, Domínguez A, Pomar F, Melgares R, Rivero F, Jiménez-Quevedo P, Gonzalo N, Fern — View Citation

Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García Del Blanco B, García-Touchard A, López-Minguéz JR, Rivero F, Masotti M, Zueco J, Cequier A, Morís C, Fernández-Ortíz A, Escaned J, Jiménez-Quevedo P, Gonzalo N, Fernández C, Macaya C; Restenosis Intra-stent — View Citation

Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García Del Blanco B, Seidelberger B, Iñiguez A, Gómez-Recio M, Masotti M, Velázquez MT, Sanchís J, García-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, López-Mínguez JR, Moreu J — View Citation

Alfonso F, Pérez-Vizcayno MJ, Dutary J, Zueco J, Cequier A, García-Touchard A, Martí V, Lozano I, Angel J, Hernández JM, López-Mínguez JR, Melgares R, Moreno R, Seidelberger B, Fernández C, Hernandez R; RIBS-III Study Investigators (under the auspices of — View Citation

Alfonso F, Pérez-Vizcayno MJ, Gómez-Recio M, Insa L, Calvo I, Hernández JM, Bullones JA, Hernández R, Escaned J, Macaya C, Gama-Ribeiro V, Leitao-Marques A; Restenosis Intrastent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators.. Implica — View Citation

Alfonso F, Pérez-Vizcayno MJ, Hernández R, Bethencourt A, Martí V, López-Mínguez JR, Angel J, Iñiguez A, Morís C, Cequier A, Sabaté M, Escaned J, Jiménez-Quevedo P, Bañuelos C, Suárez A, Macaya C; RIBS-II Investigators.. Long-term clinical benefit of siro — View Citation

Alfonso F, Pérez-Vizcayno MJ, Hernandez R, Bethencourt A, Martí V, López-Mínguez JR, Angel J, Mantilla R, Morís C, Cequier A, Sabaté M, Escaned J, Moreno R, Bañuelos C, Suárez A, Macaya C; RIBS-II Investigators.. A randomized comparison of sirolimus-eluti — View Citation

Alfonso F, Pérez-Vizcayno MJ, Hernandez R, Fernandez C, Escaned J, Bañuelos C, Bethencourt A, López-Mínguez JR, Angel J, Cequier A, Sabaté M, Morís C, Zueco J, Seabra-Gomes R; Restenosis Intra-Stent: Balloon Angioplasty Versus Elective Stent Implantation — View Citation

Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, López-Minguez JR, Angel J, Augé JM, Gómez-Recio M, Morís C, Seabra-Gomes R, Perez-Vizcayno MJ, Macaya C; Restenosis Intra-stent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators.. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up	This is a single arm study and results will be analyzed per arm. However, the angiographic and clinical results will be also compared with those obtained in other arms of previous RIBS trials	angiographic follow-up at 6-9 months
Primary	Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization)	This is a well-accepted outcome measure of individual clinical end-points. Definition of myocardial infarction is similar to that used in previous RIBS studies.	1 year of clinical follow-up
Secondary	Acute gain	Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter.	procedure
Secondary	Minimal lumen diameter	Acute angiographic parameter	procedure
Secondary	Percent diameter stenosis	Acute angiographic parameter	procedure
Secondary	Restenosis rate	Late angiographic parameter	6-9 months
Secondary	Percent diameter stenosis	Late angiographic parameter	6-9 months
Secondary	Late loss	Change in minimal lumen diameter from the final procedure to the follow-up angiogram at 6-9 months. Late angiographic parameter.	6-9 months
Secondary	Net gain	Is the difference between acute gain and late loss. Late angiographic parameter.	6-9 months
Secondary	Loss index	Late angiographic parameter	6-9 months
Secondary	Combined clinical outcome measure (Cardiac death, Myocardial infarction, target lesion revascularization)	This is a well-accepted outcome measure of individual clinical end-points. Definition of myocardial infarction is similar to that used in previous RIBS studies.	1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Cardiac death	Individual clinical outcome	1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Total mortality	Individual clinical outcome	1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Myocardial infarction	Individual clinical outcome	1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Target vessel revascularization	Individual clinical outcome	1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Target lesion revascularization	Individual clinical outcome	1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Stent thrombosis	Individual clinical outcome	1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Major bleeding	Individual clinical outcome	1 year, 2 years, 3 years, 4 years, 5 years