RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
In-Stent Restenosis |
Device: Coronary angioplasty using the paclitaxel-eluting balloon Device: Coronary angioplasty using the everolimus-eluting stent |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Minimal lumen diameter [ Time Frame: Late angiographic follow-up (6-9 months) ] [ Designated as safety issue: No ]Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography)
- Combined clinical and angiographic end-points [ Time Frame: 6-9 months, 1 year and 3 years ] [ Designated as safety issue: Yes ]
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
| Enrollment: | 190 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Paclitaxel-eluting balloon
Paclitaxel-eluting balloon (SeQuent Please, B. Braun)
|
Device: Coronary angioplasty using the paclitaxel-eluting balloon
Balloon angioplasty
|
|
Active Comparator: Everolimus-eluting stent
Everolimus-eluting stent (Xience Prime, Abbott Vascular)
|
Device: Coronary angioplasty using the everolimus-eluting stent
Stent implantation
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 20 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Spain | |
| Hospital Central de Asturias | |
| Oviedo, Asturias, Spain, 33006 | |
| Hospital Universitari de Bellvitge | |
| L'Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Hospital Universitario Marques de Valdecilla | |
| Santander, Cantabria, Spain, 39008 | |
| Hospital Universitari Son Dureta | |
| Palma de Mallorca, Illes Balears, Spain, 07014 | |
| Hospital Universitario Puerta de Hierro Majadahonda | |
| Majadahonda, Madrid, Spain, 28222 | |
| Hospital Provincial de Navarra | |
| Pamplona, Navarra, Spain, 31008 | |
| Complejo Hospitalario Universitario de Vigo | |
| Vigo, Pontevedra, Spain, 36204 | |
| Complejo Hospitalario Universitario A Coruña | |
| A Coruña, Spain, 15006 | |
| Hospital General Universitario de Alicante | |
| Alicante, Spain, 03010 | |
| Complejo Hospitalario de Torrecardenas | |
| Almeria, Spain, 04009 | |
| Hospital Universitario Infanta Cristina | |
| Badajoz, Spain, 06080 | |
| Hospital de la Santa Creu i Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital Universitari Vall d'Hebron | |
| Barcelona, Spain, 08035 | |
| Hospital Clinic de Barcelona | |
| Barcelona, Spain, 08036 | |
| Hospital Universitario Virgen de las Nieves | |
| Granada, Spain, 18014 | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Universitario La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Universitario de La Princesa | |
| Madrid, Spain, 28006 | |
| Hospital Clinico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Universitario Carlos Haya | |
| Malaga, Spain, 29010 | |
| Hospital Universitario Virgen de la Victoria | |
| Malaga, Spain, 29010 | |
| Complejo Hospitalario de Toledo | |
| Toledo, Spain, 45004 | |
| Hospital Clinico Universitario de Valencia | |
| Valencia, Spain, 46010 | |
| Hospital General Universitario de Valencia | |
| Valencia, Spain, 46014 | |
| Hospital Universitario Miguel Servet | |
| Zaragoza, Spain, 50009 | |
| Study Director: | Fernando Alfonso, MD, PhD | Hospital Clinico San Carlos, Madrid |
More Information
Publications:
| Responsible Party: | Fernando Alfonso, MD, PhD, Hospital Universitario Clínico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit, Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular |
| ClinicalTrials.gov Identifier: | NCT01239953 History of Changes |
| Other Study ID Numbers: | RIBS V |
| Study First Received: | November 12, 2010 |
| Last Updated: | February 24, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular:
|
In-stent restenosis Drug-eluting balloon Drug-eluting stent Angiography Minimal lumen diameter |
Additional relevant MeSH terms:
|
Everolimus Sirolimus Paclitaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013