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Short and Long-term Results of PCI in no Touch Vein-graft.

NCT03999398 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2021-03-09

No results posted yet for this study

Summary

Coronary artery disease is one of the biggest health issue worldwide.The treatment, in a large part of the patients, implicates a so called bypass-operation, that consists in to connect new vascular conduits (grafts) beyond the narrowed coronary vessels to improve the blood supply to the heart. One of the graft that is commonly used is the saphenous vein from the leg. The disadvantage of the saphenous vein graft is the predisposition to early obstruction. The international literature shows the following grades of occlusion: 15% in the first year and 40% after 10 year.

At the Cardio-Thoracic Clinic of the University hospital of Örebro has been developed a new method to harvest the saphenous vein together with the surrounding fat-tissue. This technique, called no-touch technique, has the advantage to reduce the damages to the vein during the harvesting, showing a substantially reduced risk for future occlusion (5% after 18 months and 10% after 8,5 years).

The aim of the PhD project is to evaluate the results of the no-touch technique in compare to the conventional technique for the venous graft harvesting. The focus of the study is to analyse all the operated patients in our clinic who underwent a post-operative coronary angiography do to angina pectoris (heart pain). All the patients who received a stent during the post-operative angiography will be analysed in detail and one will compare the occlusion grade and the rate of major adverse cardiac events (MACE).

This study is the first and the only one in the world that will examine the long-term results of the no-touch technique in particular after the stenting of the venous graft.

Conditions

  • Percutaneous Coronary Intervention
  • Saphenous Vein
  • Coronary Artery Bypass

Interventions

PROCEDURE

Percutaneous coronary intervention (PCI)

Participants are treated with a PCI and stent implantation in a venous graft (previously implanted during the CABG operation)

Sponsors & Collaborators

  • Karlstad Central Hospital

    collaborator OTHER

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Gabriele Ferrari, MD · Region Örebro Län

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2022-01-01
Completion
2022-01-02

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03999398 on ClinicalTrials.gov