NCT03999398

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

Status unknown Last updated 9 March 2021

What this trial tests

trial testing Percutaneous coronary intervention (PCI) in Percutaneous Coronary Intervention in 260 participants. Status unknown.

Timeline

1 October 2017

Primary endpoint
1 January 2022

2 January 2022

Quick facts

Lead sponsor	Region Örebro County
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	260
Start date	1 October 2017
Primary completion	1 January 2022
Estimated completion	2 January 2022
Sites	1 location across Sweden

Drugs / interventions tested

• Percutaneous coronary intervention (PCI)

Conditions studied

• Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →
• Saphenous Vein — all drugs for Saphenous Vein →
• Coronary Artery Bypass — all drugs for Coronary Artery Bypass →

Sponsor

Region Örebro County — full company profile →

Who can join

Eligibility, any sex, with Percutaneous Coronary Intervention or Saphenous Vein. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Quality of Life After Percutaneous Coronary Intervention in No-Touch Saphenous Vein Grafts is Significantly Better Than in Conventional Vein Grafts.
   Ferrari G, Karlsson J, Cao Y, Geijer H, et al · · 2022 · cited 5× · PMID 35976202 · DOI 10.21470/1678-9741-2021-0576
2. Long-term results of percutaneous coronary intervention in no-touch vein grafts are significantly better than in conventional vein grafts.
   Ferrari G, Geijer H, Cao Y, Graf U, et al · · 2025 · cited 3× · PMID 38253348 · DOI 10.1177/02676591241230012