AzTrials
AzTrials

Coronary DiseaseRAMSESNCT01722799

Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.

A study testing Drug elluting Balloon (DEB) and Drug elluting coronary stent (DES) in people with Coronary Disease, run by Andres Iñiguez Romo, MD, PhD at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. Independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization remains the main limitation, representing a challenging problem even in the DES (drug… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Disease
What is being tested?
Drug elluting Balloon (DEB) and Drug elluting coronary stent (DES)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteSpain
Study dates
Dec 2012to 6 Apr 2018
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Older than 18, informed consent.
  • Evidence of CAD with severe de novo lesion in the native coronary arteries ( ≥70% stenosis by visual estimation or >50% by CT scan); affecting
  • Vessels between 2,25 and 2,75 mm diameter and
  • The length of the coronary stenosis ≤25 mm
  • Patient informed consent form signed.

Who cannot join

  • Lesion in coronary left main ,
  • Chronic total occlusions,
  • Lesions at bifurcation,
  • Severe calcified lesions,
  • Lesions in aorto-coronary saphenous veins or arterial grafts,
  • Acute Myocardial Infarction during 48 hours before the procedure,
Show all 12Show fewer
  • Severe renal dysfunction,
  • Hypersensibility, allergy or contraindication of medication: acetylsalicylic acid, clopidogrel, ticlopidine, heparin, paclitaxel,
  • Allergy to contrast media,
  • Life expectancy less than 1 year,
  • 1 year FU not guaranteed,
  • Being participating in another study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Álvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

About this study

Official title: PROSPECTIVE RANDOMIZED TRIAL Multicentric Study to Evaluate the Treatment and the Efficiency of Paclitaxel-coated Balloon IN.PACT FALCON ® in Small-vessel Coronary Stenosis.

Significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. Independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization remains the main limitation, representing a challenging problem even in the DES (drug eluting stent) era. Recently has been developed drug eluting balloons (DEBs), which have been successfully tested in small series on in-stent restenosis, but few evidence is available in the context of small vessels disease.

The current study has been designed to know, in one hand, the clinical efficacy of the Drug elluting balloon IN.PACT FALCON and, in other hand, the effectiveness, and the cost-effectiveness incremental analysis of DEBs (IN.PACT FALCON vs. DES ( RESOLUTE INTEGRITY) in patients with de novo lesions in small vessels.

Read the detailed description

Recent studies have reported the efficacy of the local application of paclitaxel ® inhibiting neointimal proliferation, and thus the limitation of restenosis, which has led to the conception and development of drug-coated balloon or "Drug Eluting Balloons" (DEB), releasing the antiproliferative drug at the time of expansion. Initially they were applied in the treatment of in-stent restenosis. However, DEB may represent a therapeutic alternative in other contexts where anatomo-clinical uses are not always therapeutic percutaneous coronary revascularization with stent implantation, as is the case of coronary lesions located in small vessels.

Being tested
Drug elluting Balloon (DEB), Drug elluting coronary stent (DES)
Keywords
angioplasty, Percutaneous Transluminal Coronary Angioplasty, Drug elluting Balloon, Coronary Balloon, Dilatation
Medical subject headings
Coronary Disease, Dilatation, Pathologic

What participants receive

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

  • Drug elluting Balloon (DEB)Device

    Also called IN.PACT™ Falcon paclitaxel eluting balloon.

    Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue.

  • Drug elluting coronary stent (DES)Device

    Also called Resolute integrity™ zotarolimus drug coronary stent

    Percutaneous transluminal coronary angioplasty (PTCA) with stent

Study groups in NCT01722799
Study groupRoleWhat they receive
Drug elluting Balloon (DEB)ExperimentalIs a coronary dilating device with Paclitaxel ® drug delivery, for dilatation and provisional spot bare metal stenting (BMS).
Receives: Device: Drug elluting Balloon (DEB)
Drug elluting coronary stent (DES)Active comparatorThe Resolute Integrity Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.20 mm.
Receives: Device: Drug elluting coronary stent (DES)

What is being measured

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

  1. Compare the clinical efficacy measured by target vessel failure of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES).

    Target vessel failure (TVF) is define as any revascularization motivated due to myocardial infarction (with or without Q wave) or cardiac death related to the target vessel.

    Measured: The efficacy will be evaluated at 1 year.

  2. Compare the clinical security measured by the incidence MACE of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES).

    Rate of major adverse cardiac events (MACE) at 30 days, 6 months and one year. MACE was defined as cardiac death, myocardial infarction (MI) (with or without Q-wave), need for repeat revascularization of the treated vessel (surgical or repeat PCI) or occlusion of the treated lesion.

    Measured: The security will be evaluated at one month, sixth month and one year

Secondary outcomes (2)

  1. Compare the efficiency of DEBs versus DES. in terms of cost effectiveness (cost per adverse event-death avoided) and cost-utility ( cost per quality adjusted life year) in patients with de novo lesions in small vessels.

    In order to perform a cost-utility analysis, years of quality-adjusted life (QALY) gained will be measured using the quality of life questionnaire EuroQoL five dimensions (EQ-5D) and a visual scale at baseline, one month and 12 months.

    Measured: The efficiency will be evaluated at first month, 6 month and 1 year.

  2. Compare the direct cost, indirect costs and total costs of DEBs versus DES in patients with de novo lesions in small vessels.

    Measured: This outcome will be evaluated at first month, 6 month and 1 year.

Timeline

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

  1. First posted7 Nov 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionMay 2017
  4. Study completion6 Apr 2018

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01722799
Sponsor's protocol ID
MEIX-STENT-001
Other IDs
RAMSES-DEB
Acronym
RAMSES
Status last verified
Aug 2018
First submitted
25 Sep 2012
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Tepe G, Schmitmeier S, Speck U, Schnorr B, Kelsch B, Scheller B. Advances on drug-coated balloons. J Cardiovasc Surg (Torino). 2010 Feb;51(1):125-43.

    PubMed 20081769

  • Schnorr B, Kelsch B, Cremers B, Clever YP, Speck U, Scheller B. Paclitaxel-coated balloons - Survey of preclinical data. Minerva Cardioangiol. 2010 Oct;58(5):567-82.

    PubMed 20948503

  • Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.

    PubMed 19487593

Questions about this trial

What is this clinical trial studying?

A study testing Drug elluting Balloon (DEB) and Drug elluting coronary stent (DES) in people with Coronary Disease, run by Andres Iñiguez Romo, MD, PhD at 1 site 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Compare the clinical efficacy measured by target vessel failure of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES). (time frame: The efficacy will be evaluated at 1 year.). 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 NCT01722799, which also lists 3 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 2 Aug 2018.

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