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Optimized treatment of patients with severe peripheral arterial disease (Leriche-Fontaine stage IIb), when open or endovascular intervention is possible or not, in terms of measurement of pain free walking distance and further secondary end-points. - ND

Optimized treatment of patients with severe peripheral arterial disease (Leriche-Fontaine stage IIb), when open or endovascular intervention is possible or not, in terms of measurement of pain free walking distance and further secondary end-points. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001660-23-IT
Enrollment
Unknown
Registered
2009-11-16
Start date
2007-11-12
Completion date
Unknown
Last updated
2012-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteropatia obliterante cronica periferica MedDRA version: 6.1 Level: SOC Classification code 10047065

Interventions

Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Iloprost Concentration unit: % percent Concentration type: equal Concentration number: 1-

Sponsors

CENTRO STUDI FADOI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pazienti di entrambi i sessi e di eta` > 18 anni che presentino Positivita` al treadmill test eseguito con pendenza del 10% a 3 km/h: PFWD =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 3. IMA o ictus cerebri nei 6 mesi precedenti larruolamento; 4. Insufficienza cardiaca NYHA Class > II 5. Angina instabile nella fase di instabilita` 6. Coronaropatie gravi 8. Diatesi emorragica, in particolare condizioni cliniche nelle quali iloprost potrebbe aumentare il rischio di sanguinamento: ulcera gastroduodenale, trauma, emorragia cerebrale etc.. 13. Cirrosi epatica severa Child 2 14. Insufficienza renale che necessita di trattamento dialitico

Design outcomes

Primary

MeasureTime frame
Main Objective: Valutazione dell`indice di marcia libera al traedeill in pazienti con arteriopatia obliterante cronica periferica allo stadio IIb;Secondary Objective: Evoluzione di stadio della ischemia periferica; eventi vascolari maggiori; qualita` della vita; mortalita`;sicurezza del trattamento;Primary end point(s): Indice di marcia libera al treadmill (PFWD)—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026