Clinical research studies

VOYAGER

A study comparing the effects of a new anticoagulant versus placebo in patients requiring an operation to fix the blood vessels in their legs. Rivaroxaban is a drug that we already know is safe and it is used to treat patients with irregular heart rhythms or overly thick blood that is prone to clotting. As it is fairly new we do not yet know how else it can be used in patients with other medical conditions. The aim of this study is to see if it has any benefit at all on patients requiring intervention on the blood vessels in their legs. Patients will be chosen at random to either have rivaroxaban or placebo. Neither the patient nor the doctor will know which treatment the patient is receiving.

Main inclusion criteria: 

  • 50 + years
  • Moderate to severe symptomatic peripheral artery disease (PAD)
  • Technically successful operation

Main exclusion criteria:

  • Prior operation within 10 days
  • Acute limb ischemia within 2 weeks of the operation
  • Major tissue loss
  • Dual antiplatelet use for other indications, i.e. PCI (heart stents)
  • Anticogulated for another active condition (warfarin use)
    Renal failure

RECELL

A study looking at the effectiveness of a new skin graft device and how it may benefit patients with diabetic foot ulcers. The device has been used safely and with much success in patients with serious burns. Patients enrolled into this trial will give a small skin sample which will be prepared using the device for application to their diabetic foot ulcer. We will then follow patients for six months to see how well their wounds are healing.

Main inclusion criteria:

  • Stable diabetes
  • Foot ulcer measuring between 6cm2 and 100cm2
  • 18 + years

Main exclusion criteria:

  • Patient does not require surgical intervention for peripheral artery disease (PAD)
  • Patients with connective tissue disorders

ETTAA

A study looking at patients with thoracic aneurysms and the different ways in how these are treated or managed. A thoracic aneurysm is a weakening in the major blood vessel in your chest; the aorta. There has not been a large scale study such as this for this condition before so the aim of the study is to look at the different options available to patients and see if any are clearly better than others. This condition can be treated by having different types of surgery, but also with tablets, depending on the size of the aneurysm. Your consultant surgeon will decide which is the best option for you and we will collect data at regular time points to see how you are getting on.

Main inclusion criteria:

  • Chronic arch or descending aortic aneurysm ≥4cm
  • 18 + years

Main exclusion criteria:

  • Acute dissection or malperfusion syndromes (such as heart attack, stoke, limb ischemia)

ECST-2

A study looking at whether surgery, or tablets, is better for patients considered to be at risk of a stroke. When the main artery in your neck becomes blocked you are at a higher risk of having a stroke. However, it is not yet know if it is better to operate on the artery to remove the blockage, or to treat the patient with tablets and leave the artery as it is. This study aims to answer this question by having patients randomly allocated to receive one of these treatments. There is a 5 year follow up where patients will receive a number of different scans to make sure they are receiving the best treatment and they continuing to be at a reduced risk of a stroke.

Main inclusion criteria:

  • Carotid artery stenosis >50%
  • Suitable for either operation or tablets

Main exclusion criteria:

  • Recent contralateral carotid operation, cardiac or other major surgery
  • High risk patients

BASIL-2

A study looking at two different treatments for majorly diseased blood vessels in the leg. This study aims to find out whether a surgery procedure (bypass) or a small balloon inflated in the leg (angioplasty) is the best operation for patients with very diseased blood vessels. Patients will have to be fit to have both procedures and will be discussed by a team of consultants to make sure of this. Patients will be randomly chosen to have one operation or the other.

Main inclusion criteria:

  • Suitable for both bypass and angioplasty
  • Severe limb ischemia

Main exclusion criteria:

  • Previous operation to target vessel within 12 months

PREVIOUS STUDIES

Manchester Vascular Centre has a growing research portfolio that has previously featured the following studies that are now completed or closed to recruitment:
  • GEKO: This study looked at a particular medical device to see if it had any benefit on the healing of diabetic wounds.
  • RATIONALE: A study looking at a particular stent to treat patients with an aneurysm.
  • OVATION: A study looking at a particular stent to treat patients with an aneurysm.
  • IMPROVE: A study looking at emergency treatments for patients whose aneurysms have burst.