RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

In-Stent Restenosis Clinical Trial

— RIBS V  

Official title:

RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent). A Prospective, Multicenter and Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01239953
• Other study ID #: RIBS V
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 12, 2010
• Last updated: February 24, 2012
• Start date: January 2010

Study information

• Verified date: February 2012
• Source: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

Treatment of patients with bare metal stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from bare metal stent restenosis.

Description:

Treatment of patients with bare metal stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with bare metal stent restenosis.

This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with bare metal stent restenosis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

PATIENT:

• Age between 20 and 85 years

• Signed informed consent

• Acceptance of late angiographic control (6-9 months)

• Angina and / or objective evidence of ischemia

LESION:

• In-Stent restenosis (> 50% visual) any bare metal stent

• Knowledge of prior stent location

Exclusion Criteria:

PATIENT:

• Inclusion in another clinical research protocol

• Women of childbearing age

• Severe associated systemic disease (including renal or liver failure)

• Severe depression of left ventricular ejection fraction (LVEF <25%)

• Disease that affects life expectancy

• Recent myocardial infarction ( <7 days)

• Time of implantation of the previous BMS <1 month

• Severe difficulties expected for late angiographic study

LESION:

• Angiographic failure during implementation of initial stent(residual stenosis> 50%)

• Image of large thrombus in-stent (> vessel diameter)

• Tortuosity or Ca + + with very severe difficulties during prior stent deployment

• Vessel diameter <2 mm (visual estimate)

• Restenosis only "outside" the stent (The edge of the stent is not affected)

• Completely occlusive restenosis (100%, TIMI 0)

• Very diffuse restenosis (> 30 mm length)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• In-Stent Restenosis

Intervention

Device:
• Coronary angioplasty using the paclitaxel-eluting balloon
Balloon angioplasty
• Coronary angioplasty using the everolimus-eluting stent
Stent implantation

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Complejo Hospitalario de Torrecardenas	Almeria
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	Hospital Clinico San Carlos	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	Majadahonda	Madrid
Spain	Hospital Universitario Carlos Haya	Malaga
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitari Son Dureta	Palma de Mallorca	Illes Balears
Spain	Hospital Provincial de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Complejo Hospitalario de Toledo	Toledo
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Complejo Hospitalario Universitario de Vigo	Vigo	Pontevedra
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (4)

Lead Sponsor	Collaborator
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular	Abbott Vascular, B.Braun Surgical SA, Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (50)

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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. Implications of the "watermelon seeding" phenomenon during coronary interventions for in-stent restenosis. Catheter Cardiovasc Interv. 2005 Dec;66(4):521-7. — 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 sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study. J Am Coll Cardiol. 2008 Nov 11;52(20):1621-7. doi: 10.1016/j.jacc.2008.08.025. — 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-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial. J Am Coll Cardiol. 2006 Jun 6;47(11):2152-60. — View Citation

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal lumen diameter	Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography)	Late angiographic follow-up (6-9 months)	No
Secondary	Combined clinical and angiographic end-points	A) Efficacy outcomes: A1) Angiographic: 1) Restenosis rate, 2) % diameter stenosis, 3) acute gain, 4) late loss, 5) net gain A2) Composite of death, myocardial infarction, target vessel revascularization and analysis of individual events; B) Safety Outcomes: Stent thrombosis, Bleeding episodes.; C) Pre-specified variables for subgroup analysis (RIBS I); D) Stratification (length and edge). Type of stent; E) Influence of clinical variables and restenosis patterns on outcome	6-9 months, 1 year and 3 years	Yes