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NCT Number: NCT06636968

A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery

Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease. Severe calcification predicts poor prognosis and is independently associated with increased risk of cardiovascular death and morbidity. Calcification may also affect the outcome of endovascular therapy, leading to unsatisfactory vasodilation, and increase the risk of vascular complications (including restenosis) and dissection, perforation, and distal embolization. At present, according to the degree of calcification and the scope of the lesion, it can be divided into light, medium and severe three grades. Neither high pressure balloon nor atherectomy can significantly improve severe calcification. The efficacy of these treatments has also not been tested in multicenter, real-world studies. Shockwave balloon has been widely used in the clinical treatment of severe calcification due to its characteristics of significantly destroying the calcification structure, reducing the damage of vascular intima, and thus reducing postoperative complications. The currently published Disrupt PAD III Trial (NCT02923193) in calcified lesions showed shock wave balloon versus balloon expansion alone in a randomized controlled trial (RCT). The residual stenosis rate was lower (66.4% vs. 51.9%; p = 0.02), the incidence of fluid limiting intersections was low (1.4% vs. 6.8%; p = 0.03), the rate of post-expansion and recovery support was also low (5.2% vs. 17.0%; p = 0.001); (4.6% vs. 18.3%; p < 0.001). The shock wave balloon has been approved by the China Food and Drug Administration for the intracavitary treatment of severe femoral popliteal artery calcification. Due to its short market-time, it is currently only used in large vascular surgery centers. On this basis, investigators propose whether can set up a real-world study of shock wave balloon in the treatment of moderate and severe calcification, in order to explore the real efficacy of shock wave balloon in the treatment of moderate and severe calcification.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years
  • Rutherford scale: Grades 2-5.
  • Moderate-severe calcification of lower extremity arteries (defined as calcification on both sides of the arteries, the length of the lesion greater than 5cm).
  • The stenosis degree of the lesions was more than 70% confirmed by DSA, including chronic occlusive lesions.
  • At least one sub-knee branch artery is patent (defined as a run-off score of 1 or less). • In-stent restenosis or restenosis with moderate to severe calcification.
  • The stenosis degree of inflow blood vessel on the diseased side is less than 30% or the residual stenosis is less than 30% after first-stage treatment.
  • Calcification lesions with thrombus can also be included in the group after the thrombus is completely cleared.
  • Sign relevant informed consent.

Exclusion criteria

  • Active infection of the affected limb.
  • Patients with severe ischemia of the affected limb who are expected to undergo major amputation.
  • The target blood vessels were artificial blood vessels or autologous vessels.
  • Simple thrombosis lesion.
  • Thromboangiitis obliterans, arteritis or connective tissue disease-based lesions.
  • Inflow vessel stenosis is greater than 30% or residual stenosis is still greater than 30% after primary treatment.
  • Allergic to contrast agent, heparin, anti-platelet therapy.
  • Patients who are pregnant or lactating.
  • Patients with cardiovascular and cerebrovascular events such as stroke or myocardial infarction within 3 months prior to enrollment.
  • Patients who are currently in an ongoing interventional clinical study program.
  • Patients who refuse to sign informed consent. •
  • Patients who refuse to cooperate with long-term follow-up after surgery or who, for personal reasons, have difficulty communicating for quality of life assessment.

Treatment and study plan

Primary outcomes

  1. Technical Success rate

    Time frame: 7 Days

    Defined as a final residual stenosis of less than 30% without a significant dissection (grade ≥D)

Secondary outcomes

  1. Bailout stent

    Time frame: 7 Days

    The rate of bailout stent implantation.

  2. Composite MAEs and embolization

    Time frame: 1 month

    Composite end point of major amputation plus operation-associated arterial embolization.

  3. operation-associated arterial embolization

    Time frame: 7 Days

    Perioperative operation-associated arterial embolization

  4. Dissection severity

    Time frame: 1 Day

    Dissection after major procedure

  5. Dissection severity-last

    Time frame: 1 Day

    Dissection after last procesure

  6. Major amputation

    Time frame: 1 year

    Major amputation rate in different frame

  7. Primary patency

    Time frame: 1 year

    Primary patency in different frame

  8. Freedom from TLR

    Time frame: 1 year

    Freedom from TLR in different frame

  9. Rutherford category

    Time frame: 1 year

    Rutherford grading improvement score after surgery(Rutherford Classification,0-6, higher scores mean a worse outcome)

  10. quality of life score

    Time frame: 1 year

    Postoperative quality of life score(15-items quality of recovery scale after, 0-150, higher scores mean a better outcome)

  11. Indicators of health economics

    Time frame: 7 Days

    Cumulative hospitalization costs associated with target lesions and costs associated with endovascular therapy.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Dongfang Hospital Affiliated to Tongji University
  • First Affiliated Hospital of Fujian Medical University
  • First Hospital of China Medical University
  • Huashan Hospital
  • Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Qingdao Haici Hospital
  • Quanzhou First Hospital
  • RenJi Hospital
  • Second Affiliated Hospital of Soochow University
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • The Second Affiliated Hospital of Hainan Medical University
  • Xuanwu Hospital, Beijing

Registry information

Acronym: STRIKE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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