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HYbrid-Revascularisation In Senescent Cohorts: a prospective randomised comparative trial between minimally-invasive coronary revascularisation treatment without extra-corporeal circulation (off pump coronary surgery) and combined stent-implantation versus conventionally surgical treatment in cardioplegia with the aid of extra-corporeal circulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53284852
Enrollment
459
Registered
2007-02-13
Start date
2005-06-10
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Multi-vessel coronary heart disease with diseased LAD requiring surgery Circulatory System Coronary heart disease

Interventions

1. Hybrid group: surgical revascularisation of LAD with left Arteria thoracica interna-Bypass supply of dominant not interventional treatable vessels by off-pump technique. 2. Conventionally treated g

Sponsors

Martin Luther-University Halle-Wittenberg (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Coronary heart disease with diseased Left Anterior Descending coronary artery (LAD) requiring surgery 2. Male or female patients with 75 years of age or older in therapy groups 3. Male or female patients with 60 years of age or less in consecutive observed younger patients (control group) 4. Signed and dated informed consent

Exclusion criteria

Exclusion criteria: 1. Combined surgery (heart valve plus bypass) 2. Emergency treatment along with unstable cardiovascular system 3. Known intolerability of AcetylSalicylic acid (ASS), Clopidogrel and other concomitant medication required for stent-implantation 4. Participation on other clinical trials 5. Situations that limit the compliance with study requirements

Design outcomes

Primary

MeasureTime frame
Occurrence of post-operative complications (organ insufficiencies, stroke, myocardial infarction, symptomatic transitory psychotic syndrome, infection, shock, multiple systems organ failure, death) during hospitalisation.

Secondary

MeasureTime frame
1. Lethality and therapy costs during hospitalisation and in the first post-operative year 2. Survival after six and 12 month 3. Rates of complications (see primary outcomes) 4. Post-operative quality of life (Short Form health survey [SF-36], Hospital Anxiety and Depression Scale [HADS]) 5. Occurrence of postoperative complications in the group of consecutive observed younger patients (control group)

Countries

Germany

Outcome results

None listed

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