Clinical trial NCT02051088: Swedish Drug-elution Trial in Peripheral Arterial Disease
Official title: Swedish Drug-elution Trial in Peripheral Arterial Disease - a Multicenter, Prospective Randomized Controlled Clinical Trial Based on the Swedish Vascular Registry (SWEDVASC) Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Critical Limb Ischemia
Intermittent Claudication
Keywords: Critical limb ischemia
Intermittent claudication
endovascular treatment
drug-elution
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Swedish Heart Lung Foundation
name: Uppsala University
name: The Swedish National Registry for Vascular Surgery
First posted: 2014-01-31
Enrollment: 3800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Amputation rate (SWEDEPAD 1)
timeFrame: Assessed when all patients have been followed for at least one year
measure: Health-related quality of life (SWEDEPAD 2)
timeFrame: Assessed one year after randomization
Secondary outcomes:
measure: Amputation-free survival
timeFrame: Assessed when all participants have been followed for at least one, three and five years.
measure: Survival
timeFrame: Assessed when all participants have been followed for at least one, three and five years.
measure: Target lesion revascularization (TLR)
timeFrame: Assessed one year after the intervention and when all participants have been followed for one, three and five years.
measure: Time to target lesion revascularization
timeFrame: Assessed one year after the intervention and when all participants have been followed for one, three and five years.
measure: Patency
timeFrame: Assessed after 1 month and 1 year
measure: Improvement in clinical symptoms, assessed with the Rutherford classification
timeFrame: Assessed after one month and one year
measure: Health-related quality of life (SWEDEPAD 1)
timeFrame: Assessed after one year following randomisation
measure: Amputation rate (SWEDEPAD 2)
timeFrame: Assessed one year after the intervention and when all participants have been followed for one, three and five years
measure: Health-economic assessment
timeFrame: Assessed one year after the intervention and when all participants have been followed for one, three and five years
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Department of Radiology, Sahlgrenska University Hospital
name: Mårten Falkenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Vascular Surgery, Sahlgrenska University Hospital
name: Joakim Nordanstig, MD
role: STUDY_CHAIR
References:
citation: Nordanstig J, James S, Andersson M, Andersson M, Danielsson P, Gillgren P, Delle M, Engstrom J, Fransson T, Hamoud M, Hilbertson A, Johansson P, Karlsson L, Kragsterman B, Lindgren H, Ludwigs K, Mellander S, Nyman N, Renlund H, Sigvant B, Skoog P, Starck J, Tegler G, Toivola A, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Falkenberg M. Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease. N Engl J Med. 2020 Dec 24;383(26):2538-2546. doi: 10.1056/NEJMoa2005206. Epub 2020 Dec 9.