What side effects are associated with this type of intervention?

Common treatments for Critical Limb Ischemia, such as drug-eluting stents (DES) and percutaneous transluminal angioplasty (PTA), have several known side effects. DES can cause stent thrombosis, bleeding complications, and delayed healing. PTA may result in vessel dissection, restenosis, and hematoma at the puncture site. Both procedures also carry risks of infection and allergic reactions to the contrast dye used during the interventions.

What prior FDA approvals exist?

The FDA has approved several treatments for Critical Limb Ischemia (CLI), including drug-eluting stents (DES) that release medication to prevent restenosis. These stents are designed to keep the arteries open and reduce the risk of re-narrowing after the procedure. One notable example is the Zilver PTX stent, which elutes paclitaxel to inhibit cell proliferation. The DES BTK Vascular Stent System, currently under study, aims to improve patency rates in below-the-knee arteries, similar to other DES devices that have shown efficacy in maintaining vessel patency and reducing the need for repeat interventions.

What other types of research exist?

Promising novel alternatives to the DES BTK Vascular Stent System for Critical Limb Ischemia patients include: 1) Percutaneous Transluminal Angioplasty (PTA) with drug-coated balloons, which deliver medication directly to the artery wall to prevent restenosis. 2) Bioabsorbable vascular scaffolds, which provide temporary support to the artery and then dissolve, reducing long-term complications. 3) Advanced pharmacological therapies, such as new antiplatelet and anticoagulant medications, which can improve blood flow and reduce clotting risks. 4) Gene and cell-based therapies aimed at promoting angiogenesis and improving blood flow in ischemic tissues.

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Drug Eluting Stent

Drug-Eluting Stent vs PTA for Critical Limb Ischemia (SAVAL Trial)

Phase 3

Waitlist Available

Led By Jihad Mustapha, MD

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Reference vessel diameter is between 2.5 - 3.25mm for phase A RCT

Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies)

Must not have

Subject has symptomatic coronary artery disease (ie, unstable angina)

Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This study is evaluating whether a new type of stent is better than traditional stents for treating blood vessels in the legs.

Who is the study for?

This trial is for adults with critical limb ischemia, specifically in the lower limbs, who have a vessel diameter of 2.5 - 3.25mm and lesion length ≤70 mm (up to 140 mm after approval). Participants must not be pregnant, should agree to birth control if applicable, and be able to follow the trial procedures. Exclusions include life expectancy ≤1 year, recent stroke or major amputation, certain diseases like Buerger's disease or vasculitis, severe allergies to stent materials or contrast media that can't be pre-medicated.

What is being tested?

The study compares two treatments for below-the-knee artery lesions: a new Drug Eluting Stent (DES) system versus standard percutaneous transluminal angioplasty (PTA). The goal is to see if the DES provides better blood flow patency while being safe.

What are the potential side effects?

Potential side effects may include reactions at the stent placement site such as pain or bleeding, allergic reactions to stent materials or medications used during the procedure like antiplatelet therapy. There could also be risks associated with angioplasty such as blood vessel damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood vessel size fits the required range for the study.

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I have a narrowed or blocked artery in my lower leg.

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I am over 18 and have signed the consent form for the trial.

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I have one affected area in up to two blood vessels in one of my limbs.

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My target blood vessel is above the specified area near my ankle.

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A guidewire was successfully used to cross my lesion.

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I have severe leg pain due to poor blood flow, with wounds on my toes or forefoot.

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I've had successful treatment for conditions above my knee before treating my main issue.

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The total length of my lesion to be treated is 70 mm or less.

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My target lesion is higher than 4cm above my ankle.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart problems that cause chest pain.

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My blood vessel blockage is not due to hardening of the arteries.

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I am currently taking high doses of steroids or immunosuppressive medication.

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I have a blood clotting disorder.

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I cannot take blood thinners or medications that prevent blood clots.

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I have a blood clot or blockage in my arteries shown by an imaging test.

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I need treatment in more than two blood vessels.

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I have had or will have a major amputation in one of my limbs.

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I have had surgery before on the blood vessel we are looking at.

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My treatment involves special procedures for my blood vessels.

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I have severe heart failure.

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I am currently taking Canagliflozin.

Select...

I currently have an active blood infection.

Select...

I have an aneurysm in my blood vessel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Free From Major Adverse Events (MAE)

Number of Participants With Primary Patency

Other study objectives

Number of Participants Who Were Admitted to the Hospital Within 30 Days After the Index Procedure.

Number of Participants With Assisted Primary Patency

Number of Participants With Baseline Wounds Assessed as Healed

+7 more

Side effects data

From 2023 Phase 3 trial • 201 Patients • NCT03551496

10%

Peripheral arterial occlusive disease

Peripheral artery stenosis

Peripheral ischaemia

Osteomyelitis

Peripheral artery occlusion

Gangrene

Wound

Pneumonia

Cardiac failure congestive

Acute kidney injury

Limb injury

Peripheral venous disease

Pain in extremity

Back pain

Intermittent claudication

Angina pectoris

Cellulitis

Acute myocardial infarction

Gastrointestinal haemorrhage

Impaired healing

Skin ulcer

Anaemia

Vascular procedure complication

Vasospasm

Oedema peripheral

Nausea

Pulseless electrical activity

Sepsis

Dysuria

Pollakiuria

Dyspnoea

Cardiac failure

Coronary artery disease

Diarrhoea

Intestinal ischaemia

Cerebrovascular accident

Diabetic foot

Chronic kidney disease

Laceration

Haemorrhagic anaemia

Fall

Contusion

Head injury

Wound complication

Hypotension

Arterial spasm

Reperfusion injury

Haematoma

Urinary tract infection

Viral upper respiratory tract infection

Arthralgia

Muscle spasms

Neck pain

Chest pain

Catheter site haematoma

Catheter site pain

Constipation

Decubitus ulcer

Eczema

Hypoaesthesia

Epistaxis

Vertigo

Drug hypersensitivity

Dizziness

Asthenia

Arteriosclerosis

Localised infection

Peripheral artery thrombosis

Dehydration

Vomiting

Atrial fibrillation

Musculoskeletal pain

Cataract

Abscess

Corona virus infection

Restless legs syndrome

Asthma

Cough

Angina unstable

Cardiac failure chronic

Septic shock

Enterococcal bacteraemia

Abscess limb

Bradycardia

Wound infection

Device related sepsis

Aortic valve stenosis

Coronary artery occlusion

Left ventricular dysfunction

Myocardial infarction

Supraventricular tachycardia

Cardiac arrest

Atrial flutter

Subdural haematoma

Transfusion reaction

Coronary artery stenosis

Procedural pain

Ankle fracture

Sinus node dysfunction

Femur fracture

Femoral neck fracture

Wound dehiscence

Ischaemic enteritis

Enteritis

Hypoglycaemia

Hypokalaemia

Marasmus

Cerebral haemorrhage

Encephalopathy

Intervertebral disc protrusion

Pancreatitis acute

Nephropathy toxic

Haemorrhage intracranial

Syncope

Collagen-vascular disease

Vertebral foraminal stenosis

Shock hypoglycaemic

Urinary bladder haemorrhage

Ischaemic stroke

Ankle brachial index abnormal

Anticoagulation drug level above therapeutic

Cataract nuclear

Osteitis

Chronic obstructive pulmonary disease

Emphysema

Pulmonary embolism

Normochromic normocytic anaemia

Haemoglobin decreased

Weight decreased

International normalised ratio increased

Pleural effusion

Respiratory distress

Respiratory failure

Cholecystitis

Hepatic cancer

Mental status changes

Toe amputation

Rib fracture

Chest injury

Splinter

Tendon injury

Ligament sprain

Skin abrasion

Anaemia postoperative

Foot fracture

Post procedural swelling

Thermal burn

Arterial perforation

Deep vein thrombosis

Extremity necrosis

Raynaud's phenomenon

Bronchitis

Chronic sinusitis

Clostridium difficile colitis

Cystitis

Enteritis infectious

Gastroenteritis

Infected skin ulcer

Onychomycosis

Respiratory tract infection

Tinea infection

Tinea pedis

Tooth infection

Wound abscess

Foot deformity

Joint effusion

Myalgia

Spinal osteoarthritis

Trigger finger

Catheter site bruise

Peripheral swelling

Catheter site related reaction

Catheter site swelling

Fat necrosis

Non-cardiac chest pain

Pain

Pyrexia

Ulcer haemorrhage

Mouth haemorrhage

Abdominal pain

Gastrooesophageal reflux disease

Loose tooth

Diabetic ulcer

Erythema

Neurodermatitis

Plantar erythema

Rash

Skin discolouration

Cognitive disorder

Tremor

Altered state of consciousness

Carotid artery disease

Carotid artery stenosis

Demyelinating Polyneuropathy

Headache

Myelopathy

Neuralgia

Anuria

Renal cyst

Hyponatraemia

Hyperkalaemia

Hypernatraemia

Pericardial effusion

Presyncope

Costovertebral angle tenderness

Allergic cough

Hypoxia

Pulmonary oedema

Fluid overload

Gout

Hypercalcaemia

Skin cancer

Eyelid ptosis

Scleral disorder

Vitreous haemorrhage

Lung neoplasm malignant

Hepatocellular carcinoma

Prostate cancer

Inflammatory marker increased

Oxygen saturation decreased

Troponin increased

Iron deficiency anaemia

Tympanic membrane perforation

Device occlusion

Embolism

Osteomyelitis acute

Scrotal abscess

Influenza

Biliary sepsis

Diabetic foot infection

Endocarditis

Staphylococcal sepsis

Embolism arterial

Peripheral vascular disorder

Hypertension

Shock haemorrhagic

Stent-graft endoleak

Ulcer

Diabetes mellitus

Diabetic complication

Hyperglycaemia

Osteoarthritis

Acute respiratory failure

Muscle strain

Post procedural haematoma

Abdominal discomfort

Renal impairment

100%

80%

60%

40%

20%

Study treatment Arm

DES BTK

Conventional PTA

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DES BTKExperimental Treatment1 Intervention

Treatment with DES BTK

Group II: Conventional PTAActive Control1 Intervention

Treatment with standard PTA

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Drug Eluting Stent - Below the Knee

2018

Completed Phase 3

~210

0 / 24Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The DES BTK Vascular Stent System, used in treating Critical Limb Ischemia (CLI), combines mechanical and pharmacological approaches to improve blood flow in below-the-knee arteries. The stent physically props open narrowed or blocked arteries, while the drug coating (typically an antiproliferative agent) is gradually released to prevent restenosis, which is the re-narrowing of the artery. This dual action is crucial for CLI patients as it not only restores adequate blood flow to the affected limb, reducing pain and promoting healing, but also minimizes the risk of future blockages, thereby lowering the chances of severe complications such as limb amputation.