Complex Large-bore Radial Percutaneous Coronary Intervention (PCI) Trial

Complex Coronary Lesions Clinical Trial

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Official title:

Complex Large-bore Radial PCI Trial Randomized Trial Reducing Access Site Complications With Slender Technology for Complex PCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846752
• Other study ID #: 9285
• Secondary ID: NL66831.075.1818
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: August 2020
• Source: Maatschap Cardiologie Zwolle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The COLOR trial is a Multicenter Randomized trial. Patients are eligible for study participation when PCI is indicated for complex coronary lesions. If patients comply with inclusion and exclusion and provide written informed consent they will be randomized in a 1:1 fashion between the two study treatments, (7 Fr. radial access with a Glideslender sheath or 7 Fr. femoral access with a standard femoral sheath) , in a 1:1 ratio.

Description:

The COLOR trial is a Multicenter Randomized trial. Patients are eligible for study participation when PCI is indicated for complex coronary lesions. If patients comply with inclusion and exclusion and provide written informed consent they will be randomized in a 1:1 fashion between the two study treatments, (7 Fr. radial access with a Glideslender sheath or 7 Fr. femoral access with a standard femoral sheath) , in a 1:1 ratio.

During hospitalization (before discharge) the access site(s) will be checked for bleeding and vascular complications. All access sites should be checked for absent pulsations and hematomas and the size should be defined (length and width, cm) and accompanied complaints. Radial artery occlusion should be checked with the reverse Barbeau test. The femoral access site should be checked for murmurs and absence of pulsations. Ultrasound or Doppler of the access sites should be performed in those patients with suspected radial or femoral occlusion and the presence of other vascular complications, like (pseudo) aneurysms or arteriovenous (AV) fistula within 1 month.

Patient-reported extremity dysfunction will be evaluated at baseline (before the procedure) and 1-month follow-up. Upper extremity function will be evaluated with the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and lower extremity function with Lower Extremity Functional Scale questionnaire (LEFS). The occurrence of Major Adverse Cardiac Events (MACE) will be evaluated at discharge and 1-month follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: May 20, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Inability to obtain informed consent

2. contra-indication for radial or femoral access

3. Cardiogenic shock

4. ST-elevation myocardial infarction

Related Conditions & MeSH terms

• Complex Coronary Lesions

Intervention

Procedure:
• radial artery access for complex PCI
Complex PCI with access via radial artery using a 7 Fr. Glideslender sheath. PCI will be performed according to standard procedures and left to the discretion of the operator, however in case of stent placement the use of Ultimaster stents (Terumo) are highly recommended.
• femoral artery access for complex PCI
Complex PCI with access via femoral artery using a 7 Fr. standard femoral sheath . PCI will be performed according to standard procedures and left to the discretion of the operator, however in case of stent placement the use of Ultimaster stents (Terumo) are highly recommended.

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen
Belgium	CHU Charleroi	Charleroi
Belgium	Ziekenhuis Oost Limburg	Genk
Germany	Elisabeth Krankenhaus	Essen
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	OLVG	Amsterdam
Netherlands	VUMC	Amsterdam
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven
Netherlands	RadboudUMC	Nijmegen
Netherlands	Isala	Zwolle	Overijssel
Switzerland	University Hospital Geneva	Geneva
United Kingdom	Frimley Health NHS Foundation Trust, Surrey	Camberley

Sponsors (2)

Lead Sponsor	Collaborator
Maatschap Cardiologie Zwolle	Terumo Europe N.V.

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is defined as BARC 2,3 and 5 (Bleeding Academic Research Consortium) bleeding or vascular complication related to the randomized access site (during hospitalization).	The primary endpoint is defined as BARC 2,3 and 5 bleeding or vascular complication related to the randomized access site (during hospitalization).	PCI procedure till patients is discharged from the hospital, with a maximum of 30 days
Secondary	Non-access site related BARC 2,3 and 5 bleeding and/or vascular complications (hospitalization)	Non-access site related BARC 2,3 and 5 bleeding and/or vascular complications (hospitalization)	PCI procedure till patients is discharged from the hospital, with a maximum of 30 days
Secondary	MACE (hospitalization and 1-month)	MACE: Composite of death, myocardial infarction and repeat revascularization	PCI procedure till 30 days after PCI procedure
Secondary	Procedural success	Successful PCI of the target lesion with a residual stenosis of less than 20%	during PCI procedure
Secondary	procedural time	Procedural time from puncture to end procedure (in minutes)	during PCI procedure
Secondary	fluoroscopy time	fluoroscopy time (in seconds)	during PCI procedure
Secondary	contrast use	Contrast volume used (in ml)	during PCI procedure
Secondary	crossover rate	Failure to complete the procedure through the randomized access site, requiring conversion from radial to femoral access or vice versa for procedure completion	during PCI procedure