COMPLEX LARGE-BORE RADIAL PCI TRIAL

COMPLEX LARGE-BORE RADIAL PCI TRIAL - COLOR Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48821

Enrollment

236

Registered

2019-02-11

Start date

2019-03-05

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

atherosclerosis complex coronary lesion

Interventions

patients will be randomized to: - complex PCI with 7Fr catheter via the artery radialis or - complex PCI with 7Fr catheter via the artery femoralis

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Use of 7 Fr guiding catheter is indicated for complex PCI, according to the expertise of the treating physician. 2) Age 18 years or older

Exclusion criteria

Exclusion criteria: 1) Inability to obtain informed consent 2) contra-indication for radial or femoral access 3) Cardiogenic shock 4) ST elevation myocardial infarction

Design outcomes

Primary

Measure	Time frame
The primary endpoint is defined as BARC type 2, 3 or 5 bleeding or vascular complication related to the randomized access site (during hospitalization).	—

Secondary

Measure	Time frame
The secondary endpoints are defined as: 1) Non-access site related BARC type 2, 3 or 5 bleeding and/or vascular complications (hospitalization) 2) MACE (hospitalization and 1-month) 3) Procedural success, procedural time, fluoroscopy time, contrast use and crossover rate	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)