Complex Large-bore Radial Percutaneous Coronary Intervention (PCI) Trial
NCT ID: NCT03846752
Last Updated: 2020-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
388 participants
INTERVENTIONAL
2019-03-05
2020-05-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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7 Fr. radial access
radial artery access for complex PCI
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.
7 Fr. femoral access
femoral artery access for complex PCI
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Age 18 years or older.
Exclusion Criteria
2. contra-indication for radial or femoral access
3. Cardiogenic shock
4. ST-elevation myocardial infarction
18 Years
ALL
No
Sponsors
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Terumo Europe N.V.
INDUSTRY
Maatschap Cardiologie Zwolle
OTHER
Responsible Party
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Principal Investigators
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Maarten A. Van Leeuwen, MD
Role: PRINCIPAL_INVESTIGATOR
Isala
Locations
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ZNA Middelheim
Antwerp, , Belgium
CHU Charleroi
Charleroi, , Belgium
Ziekenhuis Oost Limburg
Genk, , Belgium
Elisabeth Krankenhaus
Essen, , Germany
Isala
Zwolle, Overijssel, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
OLVG
Amsterdam, , Netherlands
VUMC
Amsterdam, , Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, , Netherlands
RadboudUMC
Nijmegen, , Netherlands
University Hospital Geneva
Geneva, , Switzerland
Frimley Health NHS Foundation Trust, Surrey
Camberley, , United Kingdom
Countries
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References
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Meijers TA, Nap A, Aminian A, Dens J, Teeuwen K, van Kuijk JP, van Wely M, Schmitz T, Bataille Y, Kraaijeveld AO, Roolvink V, Hermanides RS, Braber TL, van Royen N, van Leeuwen MAH. ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial. BMJ Open. 2022 Dec 1;12(12):e065693. doi: 10.1136/bmjopen-2022-065693.
Meijers TA, Aminian A, van Wely M, Teeuwen K, Schmitz T, Dirksen MT, Rathore S, van der Schaaf RJ, Knaapen P, Dens J, Iglesias JF, Agostoni P, Roolvink V, Lemmert ME, Hermanides RS, van Royen N, van Leeuwen MAH. Extremity Dysfunction After Large-Bore Radial and Femoral Arterial Access. J Am Heart Assoc. 2022 Jan 18;11(2):e023691. doi: 10.1161/JAHA.121.023691. Epub 2022 Jan 13.
Meijers TA, Aminian A, van Wely M, Teeuwen K, Schmitz T, Dirksen MT, Rathore S, van der Schaaf RJ, Knaapen P, Dens J, Iglesias JF, Agostoni P, Roolvink V, Hermanides RS, van Royen N, van Leeuwen MAH. Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1293-1303. doi: 10.1016/j.jcin.2021.03.041. Epub 2021 May 18.
Meijers TA, Aminian A, Teeuwen K, van Wely M, Schmitz T, Dirksen MT, van der Schaaf RJ, Iglesias JF, Agostoni P, Dens J, Knaapen P, Rathore S, Ottervanger JP, Dambrink JE, Roolvink V, Gosselink ATM, Hermanides RS, van Royen N, van Leeuwen MAH. Complex Large-Bore Radial percutaneous coronary intervention: rationale of the COLOR trial study protocol. BMJ Open. 2020 Jul 20;10(7):e038042. doi: 10.1136/bmjopen-2020-038042.
Other Identifiers
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NL66831.075.18
Identifier Type: REGISTRY
Identifier Source: secondary_id
180716
Identifier Type: OTHER
Identifier Source: secondary_id
9285
Identifier Type: -
Identifier Source: org_study_id
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