Swedish Drug-elution Trial in Peripheral Arterial Disease

  • STATUS
    Recruiting
  • End date
    Oct 26, 2023
  • participants needed
    3800
  • sponsor
    Sahlgrenska University Hospital, Sweden
Updated on 26 January 2021
arteriopathy
stenosis
coronary artery disease
endovascular intervention
ischemia
vascular disease
gangrene
limb ischemia
rest pain
intermittent claudication
critical limb ischaemia
ischemic ulcer
transluminal angioplasty
endovascular procedure
revascularisation

Summary

Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation).

In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies.

In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.

Details
Condition Peripheral vascular disease, Circulation Disorders, Peripheral vascular disease, peripheral arterial disease, Peripheral Arterial Disease (PAD), Intermittent Claudication, Claudication, Intermittent Claudication, Circulation Disorders, Critical Limb Ischemia, Claudication, Critical Limb Ischaemia, Peripheral Arterial Disease (PAD), peripheral arterial diseases, peripheral artery disease
Treatment Revascularization with drug-eluting technology, Revascularization without drug-eluting technology, drug-coated balloons and/or drug-eluting stents
Clinical Study IdentifierNCT02051088
SponsorSahlgrenska University Hospital, Sweden
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All adults > 18 years old willing to be randomized
Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by >50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications

Exclusion Criteria

Acute thromboembolic disease in the leg
Infrainguinal aneurysmal disease
Previous participation in the study or in other randomised interventional study of infrainguinal lesions
Patients without a Swedish personal identification number
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note