Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
NCT Number: NCT06636968
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Shanghai, Shanghai Municipality, 200032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 7 Days
Defined as a final residual stenosis of less than 30% without a significant dissection (grade ≥D)
Time frame: 7 Days
The rate of bailout stent implantation.
Time frame: 1 month
Composite end point of major amputation plus operation-associated arterial embolization.
Time frame: 7 Days
Perioperative operation-associated arterial embolization
Time frame: 1 Day
Dissection after major procedure
Time frame: 1 Day
Dissection after last procesure
Time frame: 1 year
Major amputation rate in different frame
Time frame: 1 year
Primary patency in different frame
Time frame: 1 year
Freedom from TLR in different frame
Time frame: 1 year
Rutherford grading improvement score after surgery(Rutherford Classification,0-6, higher scores mean a worse outcome)
Time frame: 1 year
Postoperative quality of life score(15-items quality of recovery scale after, 0-150, higher scores mean a better outcome)
Time frame: 7 Days
Cumulative hospitalization costs associated with target lesions and costs associated with endovascular therapy.
Shanghai Zhongshan Hospital
Other
Acronym: STRIKE
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.
Published trials that share one or more normalized conditions with this study.
NCT04110327
Arterial Occlusive Diseases, Arteriosclerosis
Graz, Austria
View Trial DetailsNCT06832631
Arterial Occlusive Diseases, Arteriosclerosis
Aalst, Belgium
View Trial DetailsNCT04349657
Arterial Occlusive Diseases, Arteriosclerosis
Aalst, Belgium
View Trial DetailsNCT03884257
Arterial Occlusive Diseases, Arteriosclerosis
Graz, Austria
View Trial Details