The THOR IDE Study

Peripheral Artery Disease Clinical Trial

— THOR  

Official title:

The THOR IDE Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05916950
• Other study ID #: 200201
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: September 2027

Study information

• Verified date: March 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: Jennifer Moore
• Phone: 408-502-3786
• Email: theThorIDEstudy[@]philips.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).

The main question[s] it aims to answer are:

• Is the Thor system safe in treating these lesions

• Does the Thor system work to treat these lesions

Participants will:

• Receive treatment with the Thor system

• Have follow-up visits at Discharge, 30 days, 6 months, and 12 months

Description:

Up to 30 sites in the U.S. will be selected to do this study.

Patients with pain in their legs when walking and/or resting that is due to lack of blood flow to their legs may be able to join the study. To join the study patients must also have blockages in their leg arteries that meet the study criteria.

Before the Thor procedure, patients will have a screening visit that includes a review of their medical records, questions about their medical history and medications taken for blood thinning or circulation, a physical examination of their legs, a test to check the blood flow in their legs (by checking arm and leg blood pressures), blood tests, and a pregnancy test if they are a female able to have children. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

All patients in the study will have treatment with the Thor system. There is no "control group" (a group of patients that receives only standard treatment or receives no treatment at all) in this study. During the procedure, the doctor will take x-ray pictures of the leg arteries. They may also use other treatments such as angioplasty balloons, drug-coated balloons, stents, and filters that collect blood clots, if needed.

Patients treated with the Thor system will be watched until they are ready to go home or up to 24 hours after the procedure if they do not go home right away. Before they go home they will have a test to check the blood flow to their legs (by checking arm and leg blood pressures) and be checked for any adverse events.

Patients will return for visits at 30 days, 6 months, and 12 months after the Thor procedure. At these visits patients will be asked questions about their medical history and medications taken for blood thinning or circulation, have a physical examination of their legs, have a test to check the blood flow in their treated leg (by checking arm and leg blood pressures), have an ultrasound of their treated leg, and be checked for any adverse events. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

It will take up to 24 months (2 years) to enroll all of the patients in the study. Patients who join the study will be in the study for about 12 months (1 year) and will have all of the visits with their doctor that they would normally have for their PAD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 155
• Est. completion date: September 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient age is =18 years

• Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form

• Patient is able to walk unassisted or with non-motorized assistive devices

• Patient has PAD with documented Rutherford Class 2-4 of the target limb

• Life expectancy >12 months

Angiographic Inclusion Criteria:

• Patient has de novo atherosclerotic disease of the native SFA and/or the femoropopliteal arteries

• Target lesion has =70% diameter stenosis by investigator via visual assessment

• Target lesion length =150mm. Multiple lesions that are within a 150mm segment will be treated and assessed as a single lesion

• Chronic total occlusion lesion length is <100mm of the total =150mm target lesion

• Minimum reference vessel diameter (RVD) 4.0mm by visual estimate

• Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations

• At least one patent tibial vessel (defined as <50% stenosis) with runoff to the foot

• Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria

Exclusion Criteria:

• Subject has active infection requiring antibiotic therapy

• Stenting planned within the target lesion

• Known positive for COVID-19 within the last 2 weeks and actively symptomatic

• Pregnant (positive pregnancy test) or currently breast feeding

• Evidence of Acute Limb Ischemia within 7 days prior to procedure

• Cerebrovascular accident (CVA) <60 days prior to procedure

• Myocardial infarction <60 days prior to procedure

• History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment

• Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow-up

• Known allergy to contrast media that cannot adequately be premedicated prior to study procedure

• History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS)

• Serum creatinine =2.5mg/dL (unless dialysis-dependent) tested within a week prior to procedure

• Planned lower limb major amputation (above the ankle)

• Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with the exception of diagnostic angiography

• Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current trial

• The use of specialty balloons, re-entry or additional atherectomy devices

Angiographic Exclusion Criteria:

• Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated

Related Conditions & MeSH terms

• PAD
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Artery Stenosis

Intervention

Device:
• Thor laser atherectomy
Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global	NAMSA

References & Publications (49)

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Zeller T, Langhoff R, Rocha-Singh KJ, Jaff MR, Blessing E, Amann-Vesti B, Krzanowski M, Peeters P, Scheinert D, Torsello G, Sixt S, Tepe G; DEFINITIVE AR Investigators. Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. 2017 Sep;10(9):e004848. doi: 10.1161/CIRCINTERVENTIONS.116.004848. — View Citation

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Major Adverse Events (MAEs)	Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, and peri-procedural perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve	30 Days
Primary	Procedural Success	Defined as residual diameter stenosis =50% as determined by angiographic core lab	At completion of the procedure
Secondary	Target lesion patency, 30 days	Defined as freedom from CD-TLR and freedom from =50% restenosis as determined by duplex ultrasound (DUS)	30 days
Secondary	Target lesion patency, 6 months	Defined as freedom from CD-TLR and freedom from =50% restenosis as determined by duplex ultrasound (DUS)	6 months
Secondary	Target lesion patency, 12 months	Defined as freedom from CD-TLR and freedom from =50% restenosis as determined by duplex ultrasound (DUS)	12 months
Secondary	Clinically-driven target lesion revascularization	Defined as repeat revascularization procedure of the target lesion if PSVR is =2.5 by DUS or if angiography shows a percent diameter stenosis >50% and there are worsening clinical symptoms, worsening Rutherford Clinical Category or ABI that is clearly referable to the target lesion.	Through 12 months
Secondary	Technical success	Defined as the ability to deliver the Thor system and achieve residual diameter stenosis =50% after treatment with Thor and prior to adjunctive PTA, as confirmed by independent core laboratory assessments of angiographic images	Peri-procedural
Secondary	Frequency of peri-procedural adverse events	Defined as frequency of adverse events related to the investigational device (Thor system)	Within 24 hours of the procedure
Secondary	Adjunctive devices used with the Thor system	Defined as the use of other devices including angioplasty balloons, drug coated balloons, stents, embolic filters	Peri-procedural
Secondary	Ankle-Brachial Index (ABI) change, Discharge	Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at discharge compared to the baseline (Screening) value	Discharge or up to 24 hours after the procedure
Secondary	Ankle-Brachial Index (ABI) change, 30 days	Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 30 days compared to the baseline (Screening) value	30 days
Secondary	Ankle-Brachial Index (ABI) change, 6 months	Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 6 months compared to the baseline (Screening) value	6 months
Secondary	Ankle-Brachial Index (ABI) change, 12 months	Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 12 months compared to the baseline (Screening) value	12 months
Secondary	Rutherford Classification change, 30 days	Defined as the change in Rutherford classification at 30 days compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.	30 days
Secondary	Rutherford Classification change, 6 months	Defined as the change in Rutherford classification at 6 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.	6 months
Secondary	Rutherford Classification change, 12 months	Defined as the change in Rutherford classification at 12 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.	12 months
Secondary	Freedom from Major Adverse Events (MAEs)	Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, and peri-procedural perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve	Through 12 months
Secondary	Change in Short Form Health Survey (SF-36) score, 30 days	Defined as the change in SF-36 score at 30 days compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	30 days
Secondary	Change in Short Form Health Survey (SF-36) score, 6 months	Defined as the change in SF-36 score at 6 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	6 months
Secondary	Change in Short Form Health Survey (SF-36) score, 12 months	Defined as the change in SF-36 score at 12 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	12 months
Secondary	Change in Walking Impairment Questionnaire (WIQ) score, 30 days	Defined as the change in WIQ score at 30 days compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.	30 days
Secondary	Change in Walking Impairment Questionnaire (WIQ) score, 6 months	Defined as the change in WIQ score at 6 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.	6 months
Secondary	Change in Walking Impairment Questionnaire (WIQ) score, 12 months	Defined as the change in WIQ score at 12 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.	12 months