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Search / Trial NCT01327365

Trans-Radial Coronary Interventions Using A Sheathless Guiding Catheter

Launched by UNIVERSITY HOSPITAL, GENEVA · Mar 31, 2011

Trial Information

Current as of May 12, 2025

Unknown status

Keywords

Significant Coronary Artery Disease Pci Radial Approach Women Bifurcation Lesion Ostial Lesion 7 Fr Guiding Catheter Percutaneous Coronary Intervention

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • Patients need to be at least 18 years old.
  • Patients presenting with a significant coronary artery disease who qualify for PCI and who can be treated by a radial approach.
  • Any women requiring PCI who can be treated by a radial approach.
  • Any patients with a bifurcation lesion or the ostial lesion of the left anterior descending (LAD) and/or left circumflex artery (LCX), lesions commonly treated with a 7 Fr guiding catheter.
  • Bifurcation lesion = any lesion of a main epicardial vessel (i.e. LAD, LCX, right coronary artery) involving at least one major side branch (i.e. diagonal or marginal branches).
  • Ostial lesion of the LAD or LCX = presence of a significant stenosis \<5mm from the distal part of the left main.
  • Exclusion Criteria:
  • Patients who refused to give their written informed consent.
  • Male patients, in whom PCI can be easily performed with a 6 Fr standard guiding catheter (i.e. no bifurcation or ostial lesion).
  • * Patients in whom the radial approach is contra-indicated:
  • Patients with a dialysis arteria-venous fistula or in whom an arteria-venous fistula is planed in the future.
  • Patients with a known radial artery occlusion.
  • * Patients in whom a radial approach was unsuccessfully already attempted in the past (anamnestic notion or previous medical record) secondary to a:
  • Challenging vessel anatomy,
  • Vessel tortuosity,
  • Known impossibility to cannulate the coronary ostia by the radial approach.
  • * Patients in whom the Allen test results pathological bilaterally:
  • In case of pathological Allen test in one hand the other hand will be tested before choosing the femoral approach.
  • * Patients in whom the femoral approach is adopted as primary catheterization approach (at interventionist's discretion), including:
  • Unstable patients (myocardial infarction, cardiogenic shock).
  • Patients necessitating femoral access for an intra-aortic balloon counterpulsation
  • Patients presenting with a double mammary coronary graft (right and left internal mammary utilized for by-pass grafts).
  • Coronary interventions where an extreme good guiding support is mandatory (i.e. PCI of chronic total occlusion, PCI with Rotablator).
  • Particularly risky PCI (e.g., PCI of the left main artery), where the femoral approach may be more comfortable for the operator.
  • Patients requiring a femoral approach for a right heart catheterization.

About University Hospital, Geneva

The University Hospital of Geneva is a leading academic medical center committed to advancing healthcare through innovative research and clinical excellence. Renowned for its multidisciplinary approach, the hospital integrates cutting-edge medical research with high-quality patient care, fostering a collaborative environment that encourages the translation of scientific discoveries into practical treatments. As a prominent sponsor of clinical trials, the University Hospital of Geneva is dedicated to exploring new therapies and improving patient outcomes, while adhering to the highest ethical standards and regulatory compliance. Its robust infrastructure and expert clinical teams ensure the efficient execution of trials across various medical specialties, contributing significantly to the advancement of global health initiatives.

Locations

Geneva, Ge, Switzerland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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