Swedish Drug-elution Trial in Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— SWEDEPAD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02051088
• Other study ID #: SWEDEPAD
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3800
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Intermittent Claudication
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Revascularization with drug-eluting technology
Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents).
• Revascularization without drug-eluting technology
Endovascular intervention without using drug-eluting balloons or stents

Device:
• drug-coated balloons and/or drug-eluting stents

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (5)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Swedish Heart Lung Foundation, The Swedish National Registry for Vascular Surgery, The Swedish Research Council, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Amputation-free survival		Assessed when all participants have been followed for at least one, three and five years.
Secondary	Survival		Assessed when all participants have been followed for at least one, three and five years.
Secondary	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.
Secondary	Time to target lesion revascularization		Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Secondary	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
Secondary	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
Secondary	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
Secondary	Amputation rate (SWEDEPAD 2)		Assessed one year after the intervention and when all participants have been followed for one, three and five years
Secondary	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