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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Hospital Clinico San Carlos, Madrid
B.Braun Surgical SA
Abbott Vascular
Information provided by (Responsible Party):
Fernando Alfonso, MD, PhD, Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
ClinicalTrials.gov Identifier:
NCT01239953
First received: November 12, 2010
Last updated: February 24, 2012
Last verified: February 2012

November 12, 2010
February 24, 2012
January 2010
July 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01239953 on ClinicalTrials.gov Archive Site
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

Same as current
Not Provided
Not Provided
 
RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)
RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent). A Prospective, Multicenter and Randomized Clinical Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
In-Stent Restenosis
  • Device: Coronary angioplasty using the paclitaxel-eluting balloon
    Balloon angioplasty
  • Device: Coronary angioplasty using the everolimus-eluting stent
    Stent implantation
  • Active Comparator: Paclitaxel-eluting balloon
    Paclitaxel-eluting balloon (SeQuent Please, B. Braun)
    Intervention: Device: Coronary angioplasty using the paclitaxel-eluting balloon
  • Active Comparator: Everolimus-eluting stent
    Everolimus-eluting stent (Xience Prime, Abbott Vascular)
    Intervention: Device: Coronary angioplasty using the everolimus-eluting stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
190
Not Provided
July 2012   (final data collection date for primary outcome measure)

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)
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01239953
RIBS V
Yes
Fernando Alfonso, MD, PhD, Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
  • Hospital Clinico San Carlos, Madrid
  • B.Braun Surgical SA
  • Abbott Vascular
Study Director: Fernando Alfonso, MD, PhD Hospital Clinico San Carlos, Madrid
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP