Swedish Drug-elution Trial in Peripheral Arterial Disease

Study Overview
=================
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.

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

Conditions
-----------------
Peripheral Arterial Disease, Critical Limb Ischemia, Intermittent Claudication

Intervention / Treatment
-----------------
* Procedure: Revascularization with drug-eluting technology
* Procedure: Revascularization without drug-eluting technology
* Device: drug-coated balloons and/or drug-eluting stents


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revascularization with drug eluting technology<br>Revascularization with drug eluting technology | Procedure: Revascularization with drug-eluting technology<br>* Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents).<br>Device: drug-coated balloons and/or drug-eluting stents<br> <br> |
| Active Comparator: Revascularization without drug elution<br>Revascularization without drug elution technology | Procedure: Revascularization without drug-eluting technology<br>* Endovascular intervention without using drug-eluting balloons or stents<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation rate (SWEDEPAD 1) | Primary endpoint for patients with critical limb ischemia (SWEDEPAD 1) is amputation rate during follow-up, analysed when all patients have been followed for at least one year. | Assessed when all patients have been followed for at least one year | 
| Health-related quality of life (SWEDEPAD 2) | Primary endpoint for patients with intermittent claudication (SWEDEPAD 2) is health-related quality of life after one year, assessed with VascuQol-6, a disease-specific health related quality of life instrument in PAD. | Assessed one year after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation-free survival |  | Assessed when all participants have been followed for at least one, three and five years. | 
| Survival |  | Assessed when all participants have been followed for at least one, three and five years. | 
| Target lesion revascularization (TLR) | Need for re-intervention during follow-up | Assessed one year after the intervention and when all participants have been followed for one, three and five years. | 
| Time to target lesion revascularization |  | Assessed one year after the intervention and when all participants have been followed for one, three and five years. | 
| Patency | Patency, defined as freedom from binary restenosis, a reduction in lumen diameter ≥50% in patients assessed with duplex ultrasound after one month and after one year (only certain centres). | Assessed after 1 month and 1 year | 
| Improvement in clinical symptoms, assessed with the Rutherford classification | Particularly changes from Rutherford categories 4, 5 and 6 to lower categories will analysed (SWEDEPAD 1) Particularly changes from Rutherford categories 2 and 3 to other categories will analysed (SWEDEPAD 2) | Assessed after one month and one year | 
| Health-related quality of life (SWEDEPAD 1) | Health-related quality of life, assessed with the disease-specific instrument VascuQoL-6 | Assessed after one year following randomisation | 
| Amputation rate (SWEDEPAD 2) |  | Assessed one year after the intervention and when all participants have been followed for one, three and five years | 
| Health-economic assessment | Assessment of cost-effectiveness and clinical utility (only certain centres). | Assessed one year after the intervention and when all participants have been followed for one, three and five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical limb ischemia, Intermittent claudication, endovascular treatment, drug-elution