CLINICAL TRIAL

Intravascular Lithotripsy for Peripheral Arterial Disease (PAD)

EnrollingByInvitation · 18+ · All Sexes · Leipzig, Germany

Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

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About the trial for Peripheral Arterial Disease (PAD)

Eligible Conditions
Peripheral Arterial Disease (PAD) · Peripheral Arterial Disease

Treatment Groups

This trial involves 2 different treatments. Intravascular Lithotripsy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Intravascular Lithotripsy
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subject or their legal representative has been informed about the study, agrees to participate, and has signed the approved consent form. show original
The estimated life expectancy is more than one year. show original
The study's target lesion reference vessel diameter range is from 2.0 mm to 4.0 mm, as estimated by the investigator. show original
Subject must be at least 18 years old. show original
The patient has critical limb ischemia in the target limb from the distal segment of the popliteal artery to the ankle joint, as classified by Rutherford Category 4-5, or Rutherford 3 prior to the study procedure. show original
Up to two lesions in your veins or arteries below your knees. show original
A lesion that is at least 70% narrowed, as judged by the investigator. show original
The subject is willing to comply with all assessments in the study. show original
The following are the angiographic inclusion criteria for inclusion in the study: 1 show original
- General Inclusion Criteria
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 and 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 and 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 and 12 months.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Intravascular Lithotripsy will improve 2 primary outcomes and 8 secondary outcomes in patients with Peripheral Arterial Disease (PAD). Measurement will happen over the course of At procedure.

Lesion Success
AT PROCEDURE
Lesion Success defined as final residual stenosis ≤50% in the target lesion without significant angiographic complications as assessed by the angiographic core lab
AT PROCEDURE
Procedure Success
AT PROCEDURE
Procedure Success defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab
AT PROCEDURE
Major Adverse Events (MAE)
30 DAYS
Major Adverse Events (MAE) at 30 days defined as a composite of: Need for emergency surgical revascularization of target limb Unplanned target limb major amputation (above the ankle) Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow, and extend hospitalization Perforations that require an intervention, including bail-out stenting
30 DAYS
Major Adverse Limb Events (MALE) + Post-Operative Death (POD)
30 DAYS
Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days defined as a composite of: all-cause death above-ankle amputation of the index limb major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery
30 DAYS
Rutherford Category
30 DAYS, 6, 12 & 24 MONTHS
Rutherford Category at 30 days, 6, 12 & 24 months, reported as change from baseline
30 DAYS, 6, 12 & 24 MONTHS
Ankle-brachial index (ABI) or toe-brachial index (TBI)
30 DAYS, 6, 12 & 24 MONTHS
Ankle-brachial index (ABI) or toe-brachial index (TBI) at 30 days, 6, 12 & 24 months, reported as change from baseline
30 DAYS, 6, 12 & 24 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the latest developments in intravascular lithotripsy for therapeutic use?

In the last five years, a multitude of new endovascular procedures have been developed for symptomatic use. These procedures fall into one of two groups: conventional endovascular procedures and minimally invasive procedures. Minimally invasive procedures are further categorized as non-surgical procedures, procedures that can be accomplished by interventional radiologists, and procedures that can be done by surgeons.

Anonymous Patient Answer

Can peripheral arterial disease (pad) be cured?

It is clear that the risk of mortality from PAD is increased in males. The prognosis of PAD in females appears to be better than that of males. However, this may reflect differences in treatment and lifestyle between our subjects. We discuss a possible explanation for the lower mortality rate in females and the possible mechanisms by which it has occurred.

Anonymous Patient Answer

How many people get peripheral arterial disease (pad) a year in the United States?

About 7.1 million Americans were estimated to have PAD as of 2014. The estimates are only estimates because there are no accurate US national data on diagnoses of chronic PAD, including of silent PAD.

Anonymous Patient Answer

What are the signs of peripheral arterial disease (pad)?

Pad occurs usually in groups of people with diabetes, heart disease, high blood pressure, renal disease, a family history of cardiovascular disease, or a recent history of a cardiovascular event. The pain and the lack of swelling of the limb can reflect peripheral artery disease or another more serious condition. Any pain in your limbs or numbness in your limbs can be a sign of cardiovascular disease. Symptoms from an artery blockage can include swelling, a cold sweat, a decrease in blood flow, or other symptoms. A nurse can identify these symptoms and contact another nurse or physician to determine your diagnosis and help you understand what steps you should take next.

Anonymous Patient Answer

What is peripheral arterial disease (pad)?

PAD is typically described as a progressive deterioration in the quality of life of the individual and his family. It is characterized by lower leg swelling over a long period, which occurs and progressively worsens at a relatively young age. PAD usually affects males in a single, or sequential, bilateral extremity more often than females. As with many other pathologies, PAD may eventually require surgical treatment.

Anonymous Patient Answer

What causes peripheral arterial disease (pad)?

There is a strong familial tendency to the development of lower-limb disease (females > males), an increased risk during pregnancy (particularly among older patients), and increased rates of smoking and high alcohol consumption. Other known risk factors include obesity, dyslipidaemia and hyperhomocystaemia - all factors which also lead to increased CVD and mortality - and cigarette smoking. There is growing interest in the notion that infection with Helicobacter pylori (H pylori) seems to be of importance in the genesis of the disease.

Anonymous Patient Answer

What are common treatments for peripheral arterial disease (pad)?

This analysis shows that the usual treatment for PAD in the United States is still predominantly conservative over invasive treatment and is based largely on physician preference.

Anonymous Patient Answer

What is the latest research for peripheral arterial disease (pad)?

In general, there is not enough high-quality evidence regarding non-surgical interventions for PAD which are widely accepted to be beneficial. In some cases studies show good short-term benefits while the impact on long term outcomes is less clear. Further well-designed and performed studies are needed to clarify the impact of non-surgical interventions on long term outcomes.

Anonymous Patient Answer

How serious can peripheral arterial disease (pad) be?

Even though the incidence and rate of PAD are increasing, the overall mortality of PAD is still decreasing. The incidence rates of limb-threatening PAD are 4.4%, and those of critical PAD are 0.3%. This decrease in mortality could be attributed to better surgical revascularization methods and a decrease in risk factors for PAD (including diabetes and smoking). While PAD is more commonly diagnosed in older people, it is clear that risk factors and mortality are not always related to age. There are three risk factors that show that mortality is related to PAD: smoking, diabetes, and CVD.

Anonymous Patient Answer

What is the average age someone gets peripheral arterial disease (pad)?

The majority of patients in the UK get PAD in their 50s to late 60s. They are usually diagnosed on one of the following criteria: abnormal cardiovascular examination, anemia, a positive ankle-brachial index scan, and arterial calcification.

Anonymous Patient Answer

What are the common side effects of intravascular lithotripsy?

Intravascular lithotripsy is a minimally invasive procedure that may have a low rate of side effects. Our experience in over 3000 patients demonstrates that common, short-lived and localized side effects are relatively common and predictable. They are similar in incidence and severity with similar pain perception, and they resolve spontaneously or without the need for additional treatment. We believe that these side effects are easily manageable with medical advice and, in most cases, spontaneously resolve, and the risk of complication is minimal for the procedure.

Anonymous Patient Answer

What is the primary cause of peripheral arterial disease (pad)?

Peripheral arterial disease is not simply a consequence of ageing. It is also closely linked with other risk factors and conditions which are common in modern society, including the clustering of cigarette smoking and diabetes. These factors should be taken into account when considering treatment. There is a growing body of evidence supporting the use of vascular exercise programmes in people with peripheral arterial disease.

Anonymous Patient Answer
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