AzTrials
AzTrials

Coronary Artery DiseasePhase 4BABILONNCT01278186

Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions

A Phase 4 study testing Balloon angioplasty and Stent implantation in people with Coronary Artery Disease, run by B.Braun Surgical SA at 9 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Artery Disease
What is being tested?
Balloon angioplasty and Stent implantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
9 sitesSpain
Study dates
Jun 2010to Dec 2013
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • PATIENTS
  • Patients with stable angina (1-3) or unstable angina (1-3 A-C) or documented silent ischemia
  • Patients with mental and logistic conditions for the follow-up
  • Patients should accept an angiographic follow-up at 9 months, a clinical follow-up at 3 years and sign the consent
  • LESIONS
  • De-novo lesions in the bifurcations of DA/Diag either CX/OM or CD/DP with diameters in the main vessel of 2,5 to 3,8/ 2 to 3,5 and lengths < 22 mm
Show all 10Show fewer
  • The left main lesions in bifurcation are also accepted but with another independent randomization list (specify at randomization)
  • The diameter of the stenoses should be >50% in any branch with documented ischemia or more than 70% in absence of an ischemia test
  • Single vessel or multivessel disease
  • In case of a PTCA of more than one lesion, the non included lesion should be treated previously to the included lesion

Who cannot join

  • PATIENTS
  • Patients with STEMI < 72 hours
  • Patients with congestive heart failure or NYHA IV, shock or severe valvular heart disease
  • Patients with short life expectancy, or with problems for platelet antiaggregation
  • Patients in treatment with hyperthyroidism, in treatment with immunosuppression or anticoagulants, or with alcohol or drug addiction
  • Patients included in other trials
Show all 17Show fewer
  • Patients with a stroke 6 months before
  • Patients with a surgery one week before
  • Severe renal failure calculated as GF < 30 ml/min "Cockcroft Gault"
  • Women of childbearing age, with probability to become pregnant during the first year of follow-up
  • LESIONS
  • Evidence of important thrombus within the vessel to treat
  • Patients with another stent previously implanted at ≤ 15 mm from the current lesion of the study
  • Lesions affecting bypass
  • Chronic occlusions to treat
  • Restenosis in-stent or of a segment in 4 mm close to the target lesion
  • Severe calcification not totally dilatable with the balloon

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Hospital Universitario Infanta Cristina

    Badajoz, Badajoz, 06080

  • Complejo Hospitalario San Pedro de Alcantara

    Cáceres, Caceres, 10001

  • Hospital Universitario Puerta del Mar

    Cadiz, Cadiz, 11009

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen de la Victoria

    Málaga, Malaga, 29010

  • Hospital Universitari Son Dureta

    Palma de Mallorca, Balearic Islands, 07014

  • Hospital Universitario de Puerto Real

    Puerto Real, Cadiz, 11510

  • Hospital Virgen de la Salud

    Toledo, Toledo, 45004

Other trials in Spain

About this study

Official title: Prospective Randomized Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions / BABILON Study (Paclitaxel-Coated Balloon in Bifurcated Lesions)

This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.

Read the detailed description

The bifurcated coronary lesions are still a challenge for interventional cardiologists, since there is no suitable technique or strategy to manage such lesions.

This multicenter randomized prospective trial in bifurcated coronary lesions will compare the new technology of the paclitaxel-eluting balloon with the until now "gold standard" technique of the "provisional stenting" with the paclitaxel DES in the main branch.

Being tested
Balloon angioplasty, Stent implantation
Keywords
Coronary stenosis, Bifurcation, Drug-eluting balloon, Drug-eluting stent, Angiographic follow-up, Late Lumen Loss, Restenosis
Medical subject headings
Coronary Artery Disease, Coronary Stenosis

What participants receive

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

  • Balloon angioplastyProcedure or surgery

    Also called SeQuent Please

    Coronary angioplasty using the paclitaxel-coated balloon catheter

  • Stent implantationProcedure or surgery

    Also called Paclitaxel-eluting stent

    Coronary angioplasty using the paclitaxel-eluting stent

Study groups in NCT01278186
Study groupRoleWhat they receive
Paclitaxel-eluting balloonExperimentalPaclitaxel-eluting balloon catheter (SeQuent Please, B. Braun)
Receives: Procedure: Balloon angioplasty
Paclitaxel-eluting stentExperimentalPaclitaxel-eluting stent
Receives: Procedure: Stent implantation

What is being measured

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

  1. Late Lumen Loss (LLL)

    Assessment of the difference between both groups regarding the Late Lumen Loss (LLL) in main vessel and side branch, measured at late angiographic follow-up at 9 months

    Measured: Late angiographic follow-up (9 months)

  2. Restenosis

    Assessment of the difference between both groups regarding the Restenosis in both branches (proximal part of the main vessel, distal part of the main vessel and side branch), measured at late angiographic follow-up at 9 months

    Measured: Late angiographic follow-up (9 months)

Secondary outcomes (3)

  1. Thrombosis rate

    Assesment of the thrombosis rate

    Measured: Late angiographic follow-up (9 months)

  2. Target Lesion Revascularization (TLR)

    Assessment of the Target Lesion Revascularization (TLR) at late angiographic follow-up (9 months) if dilatation by restenosis or previous angiography due to angina

    Measured: Late angiographic follow-up (9 months)

  3. Major Adverse Cardiac Events (MACE)

    Assessment of the rate of Major Adverse Cardiac Events (MACE): death, AMI, Target Lesion Revascularization (TLR) - due to angina pectoris or angiographic restenosis-

    Measured: Late angiographic follow-up (9 months)

Timeline

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

  1. First posted17 Jan 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2013 (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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01278186
Sponsor's protocol ID
AAG-G-H-0909
Acronym
BABILON
Status last verified
Jul 2012
First submitted
14 Jan 2011
Last updated
17 Jul 2012
Results posted
No

Publications

  • Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.

    PubMed 16226167

  • Lefevre T, Louvard Y, Morice MC, Dumas P, Loubeyre C, Benslimane A, Premchand RK, Guillard N, Piechaud JF. Stenting of bifurcation lesions: classification, treatments, and results. Catheter Cardiovasc Interv. 2000 Mar;49(3):274-83. doi: 10.1002/(sici)1522-726x(200003)49:33.0.co;2-n.

    PubMed 10700058

  • Koo BK, Kang HJ, Youn TJ, Chae IH, Choi DJ, Kim HS, Sohn DW, Oh BH, Lee MM, Park YB, Choi YS, Tahk SJ. Physiologic assessment of jailed side branch lesions using fractional flow reserve. J Am Coll Cardiol. 2005 Aug 16;46(4):633-7. doi: 10.1016/j.jacc.2005.04.054.

    PubMed 16098427

  • Yamashita T, Nishida T, Adamian MG, Briguori C, Vaghetti M, Corvaja N, Albiero R, Finci L, Di Mario C, Tobis JM, Colombo A. Bifurcation lesions: two stents versus one stent--immediate and follow-up results. J Am Coll Cardiol. 2000 Apr;35(5):1145-51. doi: 10.1016/s0735-1097(00)00534-9.

    PubMed 10758954

  • Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004 Mar 16;109(10):1244-9. doi: 10.1161/01.CIR.0000118474.71662.E3. Epub 2004 Feb 23.

    PubMed 14981005

  • Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melian F, Herrador J, Urena I, Burgos L. Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. Am Heart J. 2004 Nov;148(5):857-64. doi: 10.1016/j.ahj.2004.05.029.

    PubMed 15523318

  • Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemela M, Kervinen K, Jensen JS, Galloe A, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L; Nordic PCI Study Group. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation. 2006 Oct 31;114(18):1955-61. doi: 10.1161/CIRCULATIONAHA.106.664920. Epub 2006 Oct 23.

    PubMed 17060387

  • Hildick-Smith D, The BBC ONE (British Bifurcation Coronary study: Old, New and Evolving strategies). Transcatheter Cardiovascular Therapeutics 2008; Oct 12-17. 2008. Washington DC. TCT 2008

  • Pan M, Suarez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Pavlovic D, Ariza J, Fernandez-Duenas J, Herrador J, Urena I. [Six-month intravascular ultrasound follow-up of coronary bifurcation lesions treated with rapamycin-eluting stents: technical considerations]. Rev Esp Cardiol. 2005 Nov;58(11):1278-86. Spanish.

    PubMed 16324581

  • Suárez de Lezo J, Medina A, Martín P, Amador C, Delgado A, Suárez de Lezo J et al. Hallazgos ultrasónicos durante el tratamiento percutáneo de lesiones coronarias en bifurcaciones. Rev Esp Cardiol 2008;61:930-5

  • Medina A, Suarez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006 Feb;59(2):183. No abstract available. Spanish.

    PubMed 16540043

  • Dzavik V, Kharbanda R, Ivanov J, Ing DJ, Bui S, Mackie K, Ramsamujh R, Barolet A, Schwartz L, Seidelin PH. Predictors of long-term outcome after crush stenting of coronary bifurcation lesions: importance of the bifurcation angle. Am Heart J. 2006 Oct;152(4):762-9. doi: 10.1016/j.ahj.2006.04.033.

    PubMed 16996856

  • Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol. 2005 Jun 21;45(12):2088-92. doi: 10.1016/j.jacc.2005.02.086.

    PubMed 15963413

  • Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30. doi: 10.1001/jama.293.17.2126.

    PubMed 15870416

  • Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.

    PubMed 14563585

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Balloon angioplasty and Stent implantation in people with Coronary Artery Disease, run by B.Braun Surgical SA at 9 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 10 inclusion and 17 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 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Late Lumen Loss (LLL) (time frame: Late angiographic follow-up (9 months)). The study lists 2 primary outcomes in all. 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 NCT01278186, which also lists 25 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 17 Jul 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in