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

Pain in extremity

Peripheral venous disease

Back pain

Pneumonia

Cardiac failure congestive

Acute kidney injury

Limb injury

Intermittent claudication

Angina pectoris

Anaemia

Skin ulcer

Oedema peripheral

Impaired healing

Vasospasm

Vascular procedure complication

Cellulitis

Acute myocardial infarction

Gastrointestinal haemorrhage

Nausea

Reperfusion injury

Urinary tract infection

Eczema

Pollakiuria

Diarrhoea

Chronic kidney disease

Dysuria

Cardiac failure

Cerebrovascular accident

Neck pain

Diabetic foot

Decubitus ulcer

Contusion

Fall

Wound complication

Arthralgia

Muscle spasms

Catheter site haematoma

Hypoaesthesia

Head injury

Haematoma

Epistaxis

Vertigo

Drug hypersensitivity

Haemorrhagic anaemia

Catheter site pain

Pulseless electrical activity

Intestinal ischaemia

Viral upper respiratory tract infection

Chest pain

Dyspnoea

Constipation

Laceration

Sepsis

Coronary artery disease

Hypotension

Arterial spasm

Dizziness

Asthenia

Arteriosclerosis

Localised infection

Peripheral artery thrombosis

Dehydration

Vomiting

Atrial fibrillation

Musculoskeletal pain

Nephropathy toxic

Collagen-vascular disease

Vertebral foraminal stenosis

Respiratory distress

Normochromic normocytic anaemia

Haemoglobin decreased

Weight decreased

Femur fracture

Splinter

Diabetic ulcer

Gout

Cardiac failure chronic

Ankle fracture

Urinary bladder haemorrhage

Rib fracture

Skin abrasion

Tremor

Carotid artery stenosis

Septic shock

Wound infection

Enterococcal bacteraemia

Angina unstable

Transfusion reaction

Extremity necrosis

Hypoglycaemia

Ischaemic enteritis

Anticoagulation drug level above therapeutic

Toe amputation

Foot fracture

Deep vein thrombosis

Corona virus infection

Cystitis

Tinea pedis

Catheter site bruise

Myelopathy

Bradycardia

Device related sepsis

Marasmus

Encephalopathy

Syncope

Thermal burn

Respiratory tract infection

Catheter site related reaction

Fat necrosis

Mouth haemorrhage

Loose tooth

Demyelinating Polyneuropathy

Headache

Allergic cough

Asthma

Cough

Hyponatraemia

Scleral disorder

Device occlusion

Hypokalaemia

Haemorrhage intracranial

Emphysema

Left ventricular dysfunction

Ischaemic stroke

Onychomycosis

Neurodermatitis

Iron deficiency anaemia

Cataract nuclear

Tendon injury

Abscess limb

Gastroenteritis

Infected skin ulcer

Tinea infection

Gastrooesophageal reflux disease

Costovertebral angle tenderness

Hypernatraemia

Myocardial infarction

Abdominal pain

Hyperkalaemia

Vitreous haemorrhage

Tympanic membrane perforation

Supraventricular tachycardia

Cerebral haemorrhage

Post procedural swelling

Arterial perforation

Enteritis infectious

Peripheral swelling

Aortic valve stenosis

Chronic obstructive pulmonary disease

Ankle brachial index abnormal

Skin cancer

Raynaud's phenomenon

Eyelid ptosis

Enteritis

Intervertebral disc protrusion

Pericardial effusion

Abscess

Coronary artery occlusion

Atrial flutter

Coronary artery stenosis

Procedural pain

Sinus node dysfunction

Pancreatitis acute

Shock hypoglycaemic

Osteitis

Respiratory failure

Ligament sprain

Bronchitis

Foot deformity

Non-cardiac chest pain

Presyncope

Hypoxia

Cardiac arrest

Femoral neck fracture

Subdural haematoma

Wound dehiscence

Pulmonary embolism

Pleural effusion

International normalised ratio increased

Cataract

Cholecystitis

Hepatic cancer

Mental status changes

Anaemia postoperative

Chest injury

Chronic sinusitis

Clostridium difficile colitis

Tooth infection

Wound abscess

Joint effusion

Myalgia

Spinal osteoarthritis

Trigger finger

Catheter site swelling

Pain

Pyrexia

Ulcer haemorrhage

Erythema

Plantar erythema

Rash

Skin discolouration

Cognitive disorder

Altered state of consciousness

Carotid artery disease

Neuralgia

Restless legs syndrome

Anuria

Renal cyst

Pulmonary oedema

Fluid overload

Hypercalcaemia

Lung neoplasm malignant

Hepatocellular carcinoma

Prostate cancer

Inflammatory marker increased

Oxygen saturation decreased

Troponin increased

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.