Swedish Drug-elution Trial in Peripheral Arterial Disease

Not Applicable

Active, not recruiting

• Conditions: Critical Limb Ischemia; Peripheral Arterial Disease; Intermittent Claudication
• Interventions: Procedure: Revascularization with drug-eluting technology; Procedure: Revascularization without drug-eluting technology; Device: drug-coated balloons and/or drug-eluting stents

• Registration Number: NCT02051088
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Study Start: 2014-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Revascularization with drug eluting technology	Revascularization with drug-eluting technology	Revascularization with drug eluting technology
Revascularization with drug eluting technology	drug-coated balloons and/or drug-eluting stents	Revascularization with drug eluting technology
Revascularization without drug elution	Revascularization without drug-eluting technology	Revascularization without drug elution technology

Primary Outcome Measures

Name	Time	Method
Amputation rate (SWEDEPAD 1)	Assessed when all patients have been followed for at least one year	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.
Health-related quality of life (SWEDEPAD 2)	Assessed one year after randomization	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.

Secondary Outcome Measures

Name	Time	Method
Survival	Assessed when all participants have been followed for at least one, three and five years.
Amputation-free survival	Assessed when all participants have been followed for at least one, three and five years.
Target lesion revascularization (TLR)	Assessed one year after the intervention and when all participants have been followed for one, three and five years.	Need for re-intervention during follow-up
Patency	Assessed after 1 month and 1 year	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).
Health-related quality of life (SWEDEPAD 1)	Assessed after one year following randomisation	Health-related quality of life, assessed with the disease-specific instrument VascuQoL-6
Health-economic assessment	Assessed one year after the intervention and when all participants have been followed for one, three and five years	Assessment of cost-effectiveness and clinical utility (only certain centres).
Time to target lesion revascularization	Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Amputation rate (SWEDEPAD 2)	Assessed one year after the intervention and when all participants have been followed for one, three and five years
Improvement in clinical symptoms, assessed with the Rutherford classification	Assessed after one month and one year	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)

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden