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In-Stent RestenosisPhase 4RIBS VNCT01239953

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

A Phase 4 study testing Coronary angioplasty using the paclitaxel-eluting balloon and Coronary angioplasty using the everolimus-eluting stent in people with In-Stent Restenosis, run by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular at 25 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
In-Stent Restenosis
What is being tested?
Coronary angioplasty using the paclitaxel-eluting balloon and Coronary angioplasty using the everolimus-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
25 sitesSpain
Study dates
Jan 2010to Jul 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 23Show fewer
  • In-Stent restenosis (> 50% visual) any bare metal stent
  • Knowledge of prior stent location
  • 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)

Who cannot join

  • PATIENT:

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Spain25 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010

  • Complejo Hospitalario de Torrecardenas

    Almería, Almeria, 04009

  • Hospital Universitario Infanta Cristina

    Badajoz, Badajoz, 06080

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada, 18014

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Carlos Haya

    Málaga, Malaga, 29010

  • Hospital Universitario Virgen de la Victoria

    Málaga, Malaga, 29010

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Hospital Universitari Son Dureta

    Palma de Mallorca, Balearic Islands, 07014

  • Hospital Provincial de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Complejo Hospitalario de Toledo

    Toledo, Toledo, 45004

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36204

  • Hospital Universitario Miguel Servet

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Coronary angioplasty using the paclitaxel-eluting balloon, Coronary angioplasty using the everolimus-eluting stent
Keywords
In-stent restenosis, Drug-eluting balloon, Drug-eluting stent, Angiography, Minimal lumen diameter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary angioplasty using the paclitaxel-eluting balloonDevice

    Balloon angioplasty

  • Coronary angioplasty using the everolimus-eluting stentDevice

    Stent implantation

Study groups in NCT01239953
Study groupRoleWhat they receive
Paclitaxel-eluting balloonActive comparatorPaclitaxel-eluting balloon (SeQuent Please, B. Braun)
Receives: Device: Coronary angioplasty using the paclitaxel-eluting balloon
Everolimus-eluting stentActive comparatorEverolimus-eluting stent (Xience Prime, Abbott Vascular)
Receives: Device: Coronary angioplasty using the everolimus-eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Late angiographic follow-up (6-9 months)

Secondary outcomes (1)

  1. Combined clinical and angiographic end-points

    1. 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

    1. Safety Outcomes: Stent thrombosis, Bleeding episodes.
    2. Pre-specified variables for subgroup analysis (RIBS I)
    3. Stratification (length and edge). Type of stent
    4. Influence of clinical variables and restenosis patterns on outcome

    Measured: 6-9 months, 1 year and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01239953
Sponsor's protocol ID
RIBS V
Acronym
RIBS V
Status last verified
Feb 2012
First submitted
12 Nov 2010
Last updated
27 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Baz JA, Pinar E, Albarran A, Mauri J; Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology. Spanish Cardiac Catheterization and Coronary Intervention Registry. 17th official report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2007). Rev Esp Cardiol. 2008 Dec;61(12):1298-314. doi: 10.1016/s1885-5857(09)60057-8. English, Spanish.

    PubMed 19080969

  • Alfonso F, Perez-Vizcayno MJ, Cruz A, Garcia J, Jimenez-Quevedo P, Escaned J, Hernandez R. Treatment of patients with in-stent restenosis. EuroIntervention. 2009 May;5 Suppl D:D70-8.

    PubMed 19736076

  • Pinar E, Albarran A, Baz JA, Mauri J. [Update on interventional cardiology]. Rev Esp Cardiol. 2009 Jan;62 Suppl 1:101-16. doi: 10.1016/s0300-8932(09)70045-4. Spanish.

    PubMed 19174054

  • Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.

    PubMed 17321312

  • Hernandez RA, Macaya C, Iniguez A, Alfonso F, Goicolea J, Fernandez-Ortiz A, Zarco P. Midterm outcome of patients with asymptomatic restenosis after coronary balloon angioplasty. J Am Coll Cardiol. 1992 Jun;19(7):1402-9. doi: 10.1016/0735-1097(92)90594-d.

    PubMed 1593031

  • Kimura T, Yokoi H, Nakagawa Y, Tamura T, Kaburagi S, Sawada Y, Sato Y, Yokoi H, Hamasaki N, Nosaka H, et al. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med. 1996 Feb 29;334(9):561-6. doi: 10.1056/NEJM199602293340903.

    PubMed 8569823

  • Lopez-Palop R, Pinar E, Lozano I, Saura D, Pico F, Valdes M. Utility of the fractional flow reserve in the evaluation of angiographically moderate in-stent restenosis. Eur Heart J. 2004 Nov;25(22):2040-7. doi: 10.1016/j.ehj.2004.07.016.

    PubMed 15541841

  • Alfonso F, Perez-Vizcayno MJ, Hernandez R, Goicolea J, Fernandez-Ortiz A, Escaned J, Banuelos C, Fernandez C, Macaya C. Long-term outcome and determinants of event-free survival in patients treated with balloon angioplasty for in-stent restenosis. Am J Cardiol. 1999 Apr 15;83(8):1268-70, A9. doi: 10.1016/s0002-9149(99)00071-5.

    PubMed 10215297

  • Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999 Nov 2;100(18):1872-8. doi: 10.1161/01.cir.100.18.1872.

    PubMed 10545431

  • Alfonso F, Cequier A, Angel J, Marti V, Zueco J, Bethencourt A, Mantilla R, Lopez-Minguez JR, Gomez-Recio M, Moris C, Perez-Vizcayno MJ, Fernandez C, Macaya C, Seabra-Gomes R; Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) Investigators. Value of the American College of Cardiology/American Heart Association angiographic classification of coronary lesion morphology in patients with in-stent restenosis. Insights from the Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) randomized trial. Am Heart J. 2006 Mar;151(3):681.e1-681.e9. doi: 10.1016/j.ahj.2005.10.014.

    PubMed 16504631

  • Alfonso F, Suarez A, Perez L, Sabate M, Moreno R, Banuelos C. Intravascular ultrasound in patients with challenging in-stent restenosis: importance of precise stent visualization. J Interv Cardiol. 2006 Apr;19(2):153-9. doi: 10.1111/j.1540-8183.2006.00123.x.

    PubMed 16650244

  • Mehran R, Mintz GS, Popma JJ, Pichard AD, Satler LF, Kent KM, Griffin J, Leon MB. Mechanisms and results of balloon angioplasty for the treatment of in-stent restenosis. Am J Cardiol. 1996 Sep 15;78(6):618-22. doi: 10.1016/s0002-9149(96)00381-5.

    PubMed 8831392

  • Reimers B, Moussa I, Akiyama T, Tucci G, Ferraro M, Martini G, Blengino S, Di Mario C, Colombo A. Long-term clinical follow-up after successful repeat percutaneous intervention for stent restenosis. J Am Coll Cardiol. 1997 Jul;30(1):186-92. doi: 10.1016/s0735-1097(97)00142-3.

    PubMed 9207641

  • Bauters C, Banos JL, Van Belle E, Mc Fadden EP, Lablanche JM, Bertrand ME. Six-month angiographic outcome after successful repeat percutaneous intervention for in-stent restenosis. Circulation. 1998 Feb 3;97(4):318-21. doi: 10.1161/01.cir.97.4.318.

    PubMed 9468204

  • Adamian M, Colombo A, Briguori C, Nishida T, Marsico F, Di Mario C, Albiero R, Moussa I, Moses JW. Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty. J Am Coll Cardiol. 2001 Sep;38(3):672-9. doi: 10.1016/s0735-1097(01)01458-9.

    PubMed 11527615

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Coronary angioplasty using the paclitaxel-eluting balloon and Coronary angioplasty using the everolimus-eluting stent in people with In-Stent Restenosis, run by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular at 25 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal lumen diameter (time frame: Late angiographic follow-up (6-9 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01239953, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.

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